PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Description of Event or Problem

Unique Complaint ID Number,Event Date,Date Entered,Manufacturer Aware Date,Brand Name,Generic Name,Model Number,Lot Number,Catalog Number,Serial Number,UDI Number,PMA / 510K Number,Date Returned to Manufacturer,Type of Reportable Event,Event Description,Manufacturer Narrative,Medical History,Patient Age,Patient Gender,Patient Weight,Date Implanted,Date Explanted,Health Effect Clinical Code,Health Effect Impact Code,Device Problem Code,Device Component Code,Investigation Type Code,Investigation Findings Code,Investigation Conclusion Code,Remedial Action Type,Latest Line Item Version;CASE-2025-00267329-1-L806,12/16/2024,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,24DM14575,71335756,,03596010598356,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Trendelenburg gait and other unspecified reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,67,Male,71,11/21/2024,12/16/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L807,12/17/2024,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,17JM04554,71337648,,03596010598479,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,58,Female,,2/13/2018,12/17/2024,E1614;E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L808,12/18/2024,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,23hm18625,71337648,,03596010598479,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Malalignment ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,61,Female,,11/18/2024,12/18/2024,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L809,1/4/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,14gm09291,71335752,,03596010598332,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,67,Male,,11/8/2014,1/4/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L810,1/6/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,19lm14033,71335754,,03596010598349,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,83,Male,,8/26/2020,1/6/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L811,1/8/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,19CM23854,71332752,,03596010597984,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,86,Female,55,7/26/2019,1/8/2025,E1906;E2401,F1905,A051201;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L812,1/15/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,24CM10539,71335754,,03596010598349,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Loosening ¿ stem and Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,61,Male,,6/20/2024,1/15/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L813,1/16/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 32MM X 52MM,71339552,24AM08840,71339552,,03596010583086,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Lysis ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Avascular Necrosis (AVN),46,Male,,7/18/2024,1/16/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L814,1/22/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,21mm05981,71337652,,03596010598493,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,62,Female,56,3/3/2022,1/22/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L815,2/4/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,24DM08755,71337650,,03596010598486,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Wear of Acetabular Component.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,71,Female,,1/8/2025,2/4/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L816,2/6/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,24HL00481,71335756,,03596010598356,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,74,Male,,1/3/2025,2/6/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L817,2/12/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,24EM06087,71335754,,03596010598349,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Trauma - Chronic; Infection - active,70,Female,,12/4/2024,2/12/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L818,2/17/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,18CM03959,71337654,,03596010598509,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,85,Female,67,8/25/2018,2/17/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L819,2/18/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 60MM,71335760,13LM17222,71335760,,03596010598370,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,80,Male,100,1/11/2016,2/18/2025,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L820,2/19/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,14GM04338,71337652,,03596010598493,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Malalignment ¿ Socket and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,67,Male,76,3/10/2015,2/19/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L821,2/20/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 36MM X MM56,71332756,24hl00493,71332756,,03596010598004,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,56,Male,,1/25/2025,2/20/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L822,2/24/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,19CM10220,71337652,,03596010598493,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,72,Female,,5/3/2019,2/24/2025,E2127;E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L823,3/4/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,13cm16451,71335752,,03596010598332,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Wear of Acetabular Component.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,76,Male,,7/25/2013,3/4/2025,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L824,3/10/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,,71332754,,03596010597991,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,66,Male,,11/22/2022,3/10/2025,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L825,3/12/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,24bm01230,71335756,,03596010598356,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,53,Female,,6/28/2024,3/12/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L826,3/13/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,16MM04467,71337650,,03596010598486,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,59,Female,,3/13/2017,3/13/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L827,3/14/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,16MM04473,71337652,,03596010598493,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,76,Female,,9/1/2017,3/14/2025,E1614;E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L828,3/19/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,24kl00142,71337652,,03596010598493,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,64,Male,101,2/28/2025,3/19/2025,E161201;E1906,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L829,3/25/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,14FM06492,71337652,,03596010598493,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,58,Male,,10/7/2017,3/25/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L830,3/26/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,23KM04805,71337648,,03596010598479,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,90,Female,,3/23/2025,3/26/2025,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L831,3/31/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,23em09758,71337650,,03596010598486,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Avascular Necrosis (AVN); Osteoarthritis,89,Female,,3/20/2024,3/31/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L832,4/1/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 36MM X 60MM,71332760,22LM07444,71332760,,03596010598028,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Malalignment ¿ Socket and Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Avascular Necrosis (AVN); Osteoarthritis,65,Male,,10/17/2023,4/1/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L833,4/1/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 32MM X 48MM,71339548,23JM10375,71339548,,03596010598790,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis; Previous Hip Surgery - Non Trauma Related,54,Female,,1/23/2024,4/1/2025,E1614;E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L834,4/2/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,23lm01715,71332754,,03596010597991,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,60,Male,,10/2/2024,4/2/2025,E1614;E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L835,4/3/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 32MM X 58MM,71339558,17JM15458,71339558,,03596010615268,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem and Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,71,Male,,6/11/2018,4/3/2025,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L836,4/13/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,24LL00490,71335754,,03596010598349,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,57,Male,,3/20/2025,4/13/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L837,4/14/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,21LM05994,71337650,,03596010598486,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Implant Fracture - stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,74,Female,,4/29/2022,4/14/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L838,4/15/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,24jl00408,71335758,,03596010598363,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,73,Female,,3/27/2025,4/15/2025,E161201;E1906,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L839,4/17/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,24CM06842,71335754,,03596010598349,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Trauma - Chronic,83,Male,,6/28/2024,4/17/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L840,4/17/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,24HL00649,71332754,,03596010597991,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,73,Female,,3/20/2025,4/17/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L841,4/23/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,14CM08118,71335756,,03596010598356,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Lysis ¿ Stem and Lysis ¿ Socket and Infection and Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,75,Female,,2/9/2017,4/23/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L842,4/23/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,23c,71335754,,03596010598349,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Loosening ¿ stem and Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,74,Male,,6/1/2023,4/23/2025,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L843,4/28/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,21AM07117,71337652,,03596010598493,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Malalignment ¿ Socket and Peri-Prosthetic Fracture ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,64,Female,,5/21/2022,4/28/2025,E161201;E1614,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L844,5/2/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 32MM X 52MM,71339552,22FM,71339552,,03596010583086,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Malalignment ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,56,Female,,12/16/2022,5/2/2025,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L845,5/2/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,24EM10197,71335758,,03596010598363,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,64,Male,,1/9/2025,5/2/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L846,5/10/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,24KL00517,71332754,,03596010597991,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,63,Male,,4/29/2025,5/10/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L847,5/12/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,20GM07820,71335752,,03596010598332,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dissociation of liner.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,75,Male,,12/10/2020,5/12/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L848,5/12/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,22CM13404,71337650,,03596010598486,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,74,Female,67,2/20/2023,5/12/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L849,5/14/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,22GM13167,71335756,,03596010598356,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Trauma - Acute (e.g. Neck Of Femur),76,Male,79,12/19/2022,5/14/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L850,5/14/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 36MM X MM56,71332756,23hm15168,71332756,,03596010598004,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,73,Female,75,2/21/2024,5/14/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L851,5/16/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 28MM X 46MM,71334946,23hm01097,71334946,,03596010598097,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,38,Female,,8/21/2024,5/16/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L852,5/20/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,18MM12963,71339550,,03596010598806,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,60,Female,,6/12/2019,5/20/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L853,5/21/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 32MM X 52MM,71339552,22KM10277,71339552,,03596010583086,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,53,Female,,5/20/2025,5/21/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L854,5/22/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,08gm18041,71335758,,03596010598363,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Trauma - Chronic,69,Male,,4/24/2013,5/22/2025,E161201;E1634;E2127,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L855,5/25/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,23mm01202,71335758,,03596010598363,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Malalignment ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,54,Female,,5/14/2024,5/25/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L856,5/28/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,24em01896,71337654,,03596010598509,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Unexplained Pain and Other.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,55,Female,,4/9/2025,5/28/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L857,5/28/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,24AL00260,71332752,,03596010597984,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,84,Female,,5/13/2025,5/28/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L858,5/31/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 28MM X 52MM,71337552,13DM06561,71337552,,03596010615206,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,81,Female,,8/3/2016,5/31/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L859,5/31/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,20GM16510,71337650,,03596010598486,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,50,Female,,2/8/2021,5/31/2025,E040203;E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L860,6/3/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,24EM06365,71335758,,03596010598363,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,57,Male,,2/18/2025,6/3/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L861,6/5/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,23GM13623,71335758,,03596010598363,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,80,Male,,11/27/2023,6/5/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L862,6/9/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,21DM02631,71339550,,03596010598806,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,97,Female,,8/5/2021,6/9/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L863,6/15/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 62MM,71335762,24GM11891,71335762,,03596010598387,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,64,Male,,5/17/2025,6/15/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L864,6/16/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 32MM X 52MM,71339552,23GM14655,71339552,,03596010583086,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem and Other.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,75,Female,,3/12/2024,6/16/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L865,6/17/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,25AL00373,71332752,,03596010597984,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,89,Female,,6/11/2025,6/17/2025,E1614;E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L866,6/18/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 58MM,71337658,17bm00731,71337658,,03596010598523,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Loosening - socket.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,63,Male,109,6/30/2021,6/18/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L867,6/26/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 32MM X 56MM,71339556,24hm13122,71339556,,03596010615251,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Wear of Acetabular Component.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,66,Male,,6/12/2025,6/26/2025,E1614;E2127;E2401,F1905,A040101;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L868,6/27/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,24bm01230,71335756,,03596010598356,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Loosening ¿ stem and Loosening - socket.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,80,Male,84,6/16/2025,6/27/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L869,6/30/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 66/70,71331266,16EM19647,71331266,,00885556020692,K211176,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Lysis ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,84,Male,,2/23/2023,6/30/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L870,6/30/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,24LL00693,71335752,,03596010598332,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,95,Male,,5/6/2025,6/30/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L871,7/1/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 32MM X 52MM,71339552,18hm13708,71339552,,03596010583086,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Trauma - Acute (e.g. Neck Of Femur),89,Male,,12/12/2018,7/1/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L872,7/1/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,24KL00705,71337648,,03596010598479,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,78,Female,,6/9/2025,7/1/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L873,7/2/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 56MM,71337656,17lm21156,71337656,,03596010598516,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,68,Female,,8/13/2018,7/2/2025,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L874,7/4/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,20EM10336,71337652,,03596010598493,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Unexplained Pain and Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,69,Female,,5/1/2024,7/4/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L875,7/7/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,22h,71337654,,03596010598509,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Malalignment ¿ Socket.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,77,Female,,1/9/2023,7/7/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L876,7/9/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,23DM11310,71335758,,03596010598363,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,65,Male,103,6/20/2025,7/9/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L877,7/10/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 28MM X 54MM,71334954,19DM16555,71334954,,03596010598134,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis; Other,82,Female,82,7/17/2014,7/10/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L878,7/15/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,19EM23932,71335754,,03596010598349,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem and Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,56,Male,90,9/24/2019,7/15/2025,E1627;E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L879,7/15/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,19JM00523,71335756,,03596010598356,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,48,Female,101,10/17/2020,7/15/2025,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L880,7/15/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,22km02991,71335754,,03596010598349,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Loosening - socket and Implant Fracture ¿ head and Other.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,87,Female,,2/14/2023,7/15/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L881,7/23/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,18DM22586,71337652,,03596010598493,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,81,Female,62,7/30/2018,7/23/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L882,7/24/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,21jm15709,71337650,,03596010598486,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Malalignment ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,66,Female,,3/25/2023,7/24/2025,E2401,F1905,A051201,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L883,7/25/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,18lm03766,71335752,,03596010598332,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,88,Female,,2/13/2019,7/25/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L884,7/25/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,25a,71339550,,03596010598806,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Other,76,Female,,7/8/2025,7/25/2025,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L885,7/28/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,25BL00442,71339550,,03596010598806,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Wear of Acetabular Component.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,59,Female,,7/8/2025,7/28/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L886,7/31/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,24KL00699,71335758,,03596010598363,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,87,Male,93,6/24/2025,7/31/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L887,8/7/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,24EM11587,71335758,,03596010598363,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,55,Male,85,11/18/2024,8/7/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L888,8/11/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,24hl00481,71335756,,03596010598356,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,69,Female,,4/4/2025,8/11/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L889,8/20/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 36MM X MM56,71332756,24BM01218,71332756,,03596010598004,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,78,Male,,9/6/2024,8/20/2025,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L890,8/21/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,24LL00484,71339550,,03596010598806,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,79,Female,,8/19/2025,8/21/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L891,8/26/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 36MM X 58MM,71332758,22JM11239,71332758,,03596010598011,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,83,Male,,4/3/2023,8/26/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L892,8/27/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,24bm01204,71332752,,03596010597984,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,70,Female,,2/24/2025,8/27/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L893,8/27/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 32MM X 52MM,71339552,24j,71339552,,03596010583086,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,81,Male,,7/14/2025,8/27/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L894,9/3/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,25CL00237,71335752,,03596010598332,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Congenital Dislocation/Dysplasia of the Hip; Osteoarthritis,63,Female,,9/2/2025,9/3/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L895,9/9/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,24JL00716,71335752,,03596010598332,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Malalignment ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis; Trauma Acute - hip fracture,71,Female,,5/23/2025,9/9/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L896,9/11/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,23km01117,71335756,,03596010598356,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,76,Male,,7/13/2024,9/11/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L897,9/15/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,24EM11578,71339550,,03596010598806,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,72,Female,,9/28/2024,9/15/2025,E1614;E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L898,9/16/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,24kl00710,71335758,,03596010598363,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,70,Male,,5/22/2025,9/16/2025,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L899,9/18/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,18BM09247,71335752,,03596010598332,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Trauma - Acute (e.g. Neck Of Femur),85,Female,,1/9/2019,9/18/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L900,9/18/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,24LL00249,71335754,,03596010598349,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Avascular Necrosis (AVN); Osteoarthritis,67,Female,,7/10/2025,9/18/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L901,9/22/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,16DM15373,71335756,,03596010598356,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Avascular Necrosis (AVN),80,Male,,3/25/2019,9/22/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L902,9/23/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 32MM X 48MM,71339548,24am01349,71339548,,03596010598790,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dissociation of liner.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,62,Female,,4/24/2024,9/23/2025,E1614;E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L903,9/24/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 36MM X 60MM,71332760,24EM20558,71332760,,03596010598028,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,76,Male,85,8/15/2025,9/24/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L904,9/27/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 36MM X MM56,71332756,25AL00259,71332756,,03596010598004,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,87,Male,,6/5/2025,9/27/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L905,9/30/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,23FM14483,71337652,,03596010598493,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Loosening ¿ stem and Other.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,81,Female,,9/24/2025,9/30/2025,E2127;E2401,F1905,A040101;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L906,10/2/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,21lm06590,71335752,,03596010598332,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Other,89,Female,59,6/28/2022,10/2/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L907,10/6/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,22hm11001,71337648,,03596010598479,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Implant Fracture - stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,56,Female,,12/8/2023,10/6/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L908,10/9/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 36MM X 58MM,71332758,24jl00409,71332758,,03596010598011,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,75,Male,,7/31/2025,10/9/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L909,10/10/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,25CL00039,71335752,,03596010598332,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,58,Female,97,8/14/2025,10/10/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L910,10/13/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 32MM X 56MM,71339556,16KM18234,71339556,,03596010615251,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Trauma - Chronic,71,Male,76,12/13/2019,10/13/2025,E1614;E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L911,10/17/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,25cl00228,71337648,,03596010598479,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,51,Female,,8/30/2025,10/17/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L912,10/17/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,24LL00249,71335754,,03596010598349,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Other Inflammatory Arthropathy; Osteoarthritis,79,Female,,9/6/2025,10/17/2025,E161201;E1614,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L913,10/20/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 58MM,71337658,18MM00808,71337658,,03596010598523,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,80,Female,77,3/28/2019,10/20/2025,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L914,10/27/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,24ll00688,71335752,,03596010598332,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation and Wear of Acetabular Component.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,43,Female,,9/12/2025,10/27/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L915,10/28/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 60MM,71335760,24am14357,71335760,,03596010598370,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,59,Male,,7/23/2024,10/28/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L916,10/29/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 60MM,71335760,23BM05212,71335760,,03596010598370,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,61,Male,124,1/8/2024,10/29/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L917,10/30/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,19dm09935,71335758,,03596010598363,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Implant Fracture ¿ head.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Other Inflammatory Arthropathy; Osteoarthritis,81,Male,79,2/25/2020,10/30/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L918,11/3/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,21DM01698,71332752,,03596010597984,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Malalignment ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Other Inflammatory Arthropathy,63,Female,,6/15/2021,11/3/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L919,11/4/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,17CM08201,71335758,,03596010598363,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,52,Male,,1/18/2018,11/4/2025,E1614;E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L920,11/8/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 58MM,71335758,23bm10676,71335758,,03596010598363,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,70,Male,,7/28/2025,11/8/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L921,11/9/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,25AL00575,71337648,,03596010598479,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,64,Female,,6/24/2025,11/9/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L922,11/10/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,11LM03079,71337650,,03596010598486,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,87,Female,,2/24/2012,11/10/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L923,11/11/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,24CM02357,71332754,,03596010597991,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,78,Male,,8/19/2025,11/11/2025,E2330;E2401,F1905,A2303;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L924,11/12/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,15LM07844,71339550,,03596010598806,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,61,Male,,9/3/2018,11/12/2025,E2401,F1905,A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L925,11/12/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 62MM,71335762,25AL00392,71335762,,03596010598387,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,66,Male,,9/2/2025,11/12/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L926,11/13/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG +4 XLPE ACET LNR 36MM X 56MM,71338556,19AM23803,71338556,,03596010598738,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Avascular Necrosis (AVN),55,Male,,3/1/2021,11/13/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L927,11/13/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 32MM X 56MM,71339556,19fm12561,71339556,,03596010615251,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,80,Male,,8/26/2023,11/13/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L928,11/15/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,22HM00438,71335756,,03596010598356,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,70,Male,,3/27/2023,11/15/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L929,11/17/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,24LL00182,71335754,,03596010598349,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Trauma Acute - hip fracture,60,Male,,6/5/2025,11/17/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L930,11/19/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 52MM,71337652,08LM12109,71337652,,03596010598493,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,90,Female,,1/28/2011,11/19/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L931,11/19/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,19DM06568,71335752,,03596010598332,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Malalignment ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,77,Male,75,6/29/2019,11/19/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L932,11/21/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 32MM X 48MM,71339548,25CL00579,71339548,,03596010598790,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,63,Female,,10/23/2025,11/21/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L933,11/23/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 32MM X 52MM,71339552,24l,71339552,,03596010583086,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,80,Female,,10/11/2025,11/23/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L934,11/29/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,25CL00241,71335756,,03596010598356,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Congenital Dislocation/Dysplasia of the Hip; Osteoarthritis,69,Male,80,11/28/2025,11/29/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L935,12/3/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 32MM X 48MM,71339548,25al00402,71339548,,03596010598790,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Avascular Necrosis (AVN); Osteoarthritis,32,Male,,11/26/2025,12/3/2025,E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L936,12/5/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 36MM X 54MM,71332754,24ll00478,71332754,,03596010597991,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,67,Male,,9/15/2025,12/5/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L937,12/8/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,23KM09673,71332752,,03596010597984,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,72,Female,79,7/20/2024,12/8/2025,E1634;E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L938,12/9/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 60MM,71335760,21GM21170,71335760,,03596010598370,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Malalignment ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,59,Male,,6/10/2022,12/9/2025,E040203,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L939,12/11/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 60MM,71335760,22km10939,71335760,,03596010598370,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Loosening ¿ stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,87,Male,,4/28/2023,12/11/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L940,12/16/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 48MM,71337648,19fm16583,71337648,,03596010598479,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Peri-Prosthetic Fracture ¿ Stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Congenital Dislocation/Dysplasia of the Hip,58,Female,,7/3/2020,12/16/2025,E1614,F1905,A24;A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L941,12/19/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 56MM,71335756,25EL00718,71335756,,03596010598356,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,63,Male,,11/8/2025,12/19/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L942,12/23/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 60MM,71335760,19MM01722,71335760,,03596010598370,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Avascular Necrosis (AVN); Osteoarthritis,76,Male,,8/11/2021,12/23/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L943,12/30/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 32MM X 50MM,71339550,24LM02924,71339550,,03596010598806,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Adverse Soft Tissue Reaction to Particulate Debris.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,72,Female,,10/18/2025,12/30/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L944,12/31/2025,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 54MM,71335754,24LL00249,71335754,,03596010598349,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Other Inflammatory Arthropathy; Osteoarthritis,71,Female,88,5/3/2025,12/31/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L945,1/5/2026,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,25d,71337650,,03596010598486,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,67,Female,,11/3/2025,1/5/2026,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L946,1/9/2026,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 36MM X 52MM,71332752,19fm18769,71332752,,03596010597984,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,86,Female,,10/8/2019,1/9/2026,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L947,1/12/2026,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 54MM,71337654,24km14250,71337654,,03596010598509,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,62,Male,,7/9/2025,1/12/2026,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L948,1/19/2026,7/21/2026,4/1/2026,R3 Acetabular System,R3 0 DEG XLPE ACET LNR 36MM X 58MM,71332758,21lm02262,71332758,,03596010598011,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Dissociation of liner.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Trauma - Acute (e.g. Neck Of Femur),79,Male,,4/6/2022,1/19/2026,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L949,1/20/2026,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 36MM X 52MM,71335752,23AM18121,71335752,,03596010598332,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Other.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Osteoarthritis,81,Female,81,5/9/2023,1/20/2026,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267329-1-L950,1/20/2026,7/21/2026,4/1/2026,R3 Acetabular System,R3 20 DEG XLPE ACET LNR 32MM X 50MM,71337650,24GM04220,71337650,,03596010598486,K113848,,IN,"It was reported that, based on data from the National Joint Registry (NJR) from United Kingdom, a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 using an R3 XLPE Acetabular Liner. Of these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA between 13-May-2007 and 26-Jan-2026 in which a R3 XLPE Acetabular Liner was implanted. Of these, nine hundred and fifty (950) hips required revision due to the following reasons: two hundred thirty four (234) hips due to infection, two hundred eighty four (284) due to dislocation or subluxation, one hundred sixty one (161) due to periprosthetic fracture of the stem, eighty nine (89) due to periprosthetic fracture, fifty six (56) due to aseptic loosening of the stem, forty eight (48) due to socket malalignment, forty (40) due to other reasons, thirty one (31) due to pain, twenty three (23) due to stem malalignment, twenty one (21) due to adverse soft tissue reaction to particulate debris, twenty (20) due to aseptic loosening of the socket, fourteen (14) due to wear of the acetabular component, twelve (12) due to implant fracture of the stem, eleven (11) due to periprosthetic fracture of the socket, ten (10) due to lysis of the stem, eight (8) due to implant fracture of a non ceramic component of the stem, eight (8) due to leg length discrepancy, seven (7) due to dissociation of the liner, five (5) due to incorrect sizing of the head, four (4) due to lysis of the socket, two (2) due to implant fracture of the head, two (2) due to implant fracture of a non ceramic component of the head, two (2) due to incorrect sizing of the socket, two (2) due to implant fracture of a non ceramic component of the socket, one (1) due to implant fracture of the socket, one (1) due to implant fracture of a ceramic component of the stem, and one (1) due to implant fracture of a ceramic component of the socket.;Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 13-May-2007 and 26-Jan-2026 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total seventy-five thousand three hundred and seventy-nine (75,379) hips underwent primary THA in which a R3 XLPE Acetabular Liner was implanted in United Kingdom between 13-May-2007 and 26-Jan-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;- At 5th postoperative year: 9.09% (1.33%-49.19%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year:9.09% (1.33%-49.19%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 0 Degree Liner;- At 1st postoperative year: 0.79% (0.68%-0.91%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.09% (0.96%-1.24%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.32% (1.16%-1.49%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.94% (1.68%-2.24%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 2.53% (1.74%-3.66%) vs 6.29% (6.19%-6.40%) of the class;R3 XLPE 20 Degree +4mm Lateralized Liner:;- At 1st postoperative year: 1.52% (0.49%-4.62%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 3.63% (1.43%-9.03%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 5.68% (2.27%-13.83%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 5.68% (2.27%-13.83%) vs 4.08% (4.02%-4.14%) of the class;R3 XLPE 20 Degree Hooded Liner;- At 1st postoperative year: 0.70% (0.63%-0.77%) vs 0.91% (0.89%-0.94%) of the class;- At 3rd postoperative year: 1.02% (0.93%-1.12%) vs 1.60% (1.57%-1.63%) of the class;- At 5th postoperative year: 1.29% (1.18%-1.41%) vs 2.25% (2.21%-2.29%) of the class;- At 10th postoperative year: 1.93% (1.76%-2.12%) vs 4.08% (4.02%-4.14%) of the class;- At 15th postoperative year: 3.10% (2.22%-4.32%) vs 6.29% (6.19%-6.40%) of the class;By observing the cumulative revision rates above, it can be determined that there is no statistically significant difference between the revision rates of the R3 XLPE Liner variants and the NJR cementless THA class at the postoperative years evaluated, as determined by overlapping 95% confidence intervals. The only exceptions are the R3 XLPE 0 Degree Liner and the R3 XLPE 20 Degree Hooded Liner, which present a statistically significant difference between in revision rates compared to the NJR cementless THA class, at Years 3, 5, 10, and 15, and Years 1, 3, 5, 10, and 15 respectively, as determined by non-overlapping 95% confidence intervals. At each evaluated time point, these two variants demonstrate statistically significantly lower cumulative revision rates compared with the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Osteoarthritis,68,Female,,1/8/2026,1/20/2026,E161201,F1905,A0102,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L79,4/30/2015,7/21/2026,4/1/2026,R3 Acetabular system,R3 CONSTRAINED ACETABULAR LINER 66-70MM,71339166,09jm17172r,71339166,,00885556021620,K211176,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of nine hundred sixty two (962) hips underwent revision THA procedures between 10-Sep-2008 and 20-Jan-2026, using an R3 XLPE Acetabular Liner. From these, one (1) hip was later re-revised due to:Loosening of socket, Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of nine hundred sixty two (962) hips underwent revision THA procedures between 10-Sep-2008 and 20-Jan-2026, using an R3 XLPE Acetabular Liner. From these, eighty nine (89) hips were later re-revised due to the following complications: twenty four (24) hips due to dislocation/subluxation, twenty three (23) hips due to infection, fifteen (15) hips due to aseptic loosening of the socket, eleven (11) hips due to periprosthetic fracture of the stem, ten (10) hips due to pain, eight (8) hips due to aseptic loosening of the stem, six (6) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to malalignment of the socket, two (2) hips due to other-unknown reasons, and two (2) hips due to wear of the acetabular component, and one (1) hip due to liner dissociation, one (1) hip due to peri prosthetic fracture, one (1) hip due to stem lysis, and one (1) hip due to periprosthetic fracture of the socket. It should be noted that more than one reason for revision may be listed for each revision surgery.; ;Timeframe of Registry Data: Implantations conducted between 10-Sep-2008 and 20-Jan-2026 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred sixty two (962) revision THA procedures with R3 XLPE Acetabular Liners have been performed in the United Kingdom between 10-Sep-2008 and 20-Jan-2026. ;;The mean cumulative re-revision rates for the R3 XLPE Acetabular Liners were in line or lower with the mean cumulative re-revision rates for the THA NJR class (22nd Annual report) across all years of follow-up data available. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;-At 1st postoperative year: 11.18% (2.91%-37.93%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 18.59% (6.28%-47.91%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 25.99% (10.44%-56.01%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 25.99% (10.44%-56.01%) vs 15.26% (14.87%-15.65%) of the class;;R3 XLPE 0 Degree Liner;-At 1st postoperative year: 2.97% (0.97%-8.93%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 6.02% (2.75%-12.92%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 8.21% (4.18%-15.77%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 9.52% (5.05%-17.57%) vs 15.26% (14.87%-15.65%) of the class;-At 15th postoperative year: 12.44% (6.43%-23.32%) vs 18.82% (18.20%-19.46%) of the class;;R3 XLPE 20 Degree +4mm Lateralized Liner;-At 1st postoperative year: 7.77% (2.57%-22.2%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 15.91% (7.47%-32.06%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 19.02% (9.52%-35.92%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 19.02% (9.52%-35.92%) vs 15.26% (14.87%-15.65%) of the class;;R3 XLPE 20 Degree Hooded Liner;-At 1st postoperative year: 4.97% (3.66%-6.74%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 6.85% (5.28%-8.87%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 7.76% (6.06%-9.91%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 8.99% (7.09%-11.38%) vs 15.26% (14.87%-15.65%) of the class;-At 15th postoperative year: 11.1% (7.95%-15.38%) vs 18.82% (18.20%-19.46%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision:Wear of Acetabular Component.,66,Male,,10/30/2013,,E161201;E1614,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L80,5/22/2014,7/21/2026,4/1/2026,R3 Acetabular system,R3 CONSTRAINED ACETABULAR LINER 66-70MM,71339166,0CM00631R,71339166,,00885556021620,K211176,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of nine hundred sixty two (962) hips underwent revision THA procedures between 10-Sep-2008 and 20-Jan-2026, using an R3 XLPE Acetabular Liner. From these, one (1) hip was later re-revised due to:Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of nine hundred sixty two (962) hips underwent revision THA procedures between 10-Sep-2008 and 20-Jan-2026, using an R3 XLPE Acetabular Liner. From these, eighty nine (89) hips were later re-revised due to the following complications: twenty four (24) hips due to dislocation/subluxation, twenty three (23) hips due to infection, fifteen (15) hips due to aseptic loosening of the socket, eleven (11) hips due to periprosthetic fracture of the stem, ten (10) hips due to pain, eight (8) hips due to aseptic loosening of the stem, six (6) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to malalignment of the socket, two (2) hips due to other-unknown reasons, and two (2) hips due to wear of the acetabular component, and one (1) hip due to liner dissociation, one (1) hip due to peri prosthetic fracture, one (1) hip due to stem lysis, and one (1) hip due to periprosthetic fracture of the socket. It should be noted that more than one reason for revision may be listed for each revision surgery.; ;Timeframe of Registry Data: Implantations conducted between 10-Sep-2008 and 20-Jan-2026 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred sixty two (962) revision THA procedures with R3 XLPE Acetabular Liners have been performed in the United Kingdom between 10-Sep-2008 and 20-Jan-2026. ;;The mean cumulative re-revision rates for the R3 XLPE Acetabular Liners were in line or lower with the mean cumulative re-revision rates for the THA NJR class (22nd Annual report) across all years of follow-up data available. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;-At 1st postoperative year: 11.18% (2.91%-37.93%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 18.59% (6.28%-47.91%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 25.99% (10.44%-56.01%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 25.99% (10.44%-56.01%) vs 15.26% (14.87%-15.65%) of the class;;R3 XLPE 0 Degree Liner;-At 1st postoperative year: 2.97% (0.97%-8.93%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 6.02% (2.75%-12.92%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 8.21% (4.18%-15.77%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 9.52% (5.05%-17.57%) vs 15.26% (14.87%-15.65%) of the class;-At 15th postoperative year: 12.44% (6.43%-23.32%) vs 18.82% (18.20%-19.46%) of the class;;R3 XLPE 20 Degree +4mm Lateralized Liner;-At 1st postoperative year: 7.77% (2.57%-22.2%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 15.91% (7.47%-32.06%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 19.02% (9.52%-35.92%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 19.02% (9.52%-35.92%) vs 15.26% (14.87%-15.65%) of the class;;R3 XLPE 20 Degree Hooded Liner;-At 1st postoperative year: 4.97% (3.66%-6.74%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 6.85% (5.28%-8.87%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 7.76% (6.06%-9.91%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 8.99% (7.09%-11.38%) vs 15.26% (14.87%-15.65%) of the class;-At 15th postoperative year: 11.1% (7.95%-15.38%) vs 18.82% (18.20%-19.46%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision:Peri-Prosthetic Fracture Socket.,71,Female,,5/13/2014,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L81,6/23/2020,7/21/2026,4/1/2026,R3 Acetabular system,R3 CONSTRAINED ACETABULAR LINER 58MM,71339158,12KM08893,71339158,,00885556020876,K211176,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of nine hundred sixty two (962) hips underwent revision THA procedures between 10-Sep-2008 and 20-Jan-2026, using an R3 XLPE Acetabular Liner. From these, one (1) hip was later re-revised due to:Dislocation/Subluxation, Dissociation of liner.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of nine hundred sixty two (962) hips underwent revision THA procedures between 10-Sep-2008 and 20-Jan-2026, using an R3 XLPE Acetabular Liner. From these, eighty nine (89) hips were later re-revised due to the following complications: twenty four (24) hips due to dislocation/subluxation, twenty three (23) hips due to infection, fifteen (15) hips due to aseptic loosening of the socket, eleven (11) hips due to periprosthetic fracture of the stem, ten (10) hips due to pain, eight (8) hips due to aseptic loosening of the stem, six (6) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to malalignment of the socket, two (2) hips due to other-unknown reasons, and two (2) hips due to wear of the acetabular component, and one (1) hip due to liner dissociation, one (1) hip due to peri prosthetic fracture, one (1) hip due to stem lysis, and one (1) hip due to periprosthetic fracture of the socket. It should be noted that more than one reason for revision may be listed for each revision surgery.; ;Timeframe of Registry Data: Implantations conducted between 10-Sep-2008 and 20-Jan-2026 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred sixty two (962) revision THA procedures with R3 XLPE Acetabular Liners have been performed in the United Kingdom between 10-Sep-2008 and 20-Jan-2026. ;;The mean cumulative re-revision rates for the R3 XLPE Acetabular Liners were in line or lower with the mean cumulative re-revision rates for the THA NJR class (22nd Annual report) across all years of follow-up data available. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;-At 1st postoperative year: 11.18% (2.91%-37.93%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 18.59% (6.28%-47.91%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 25.99% (10.44%-56.01%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 25.99% (10.44%-56.01%) vs 15.26% (14.87%-15.65%) of the class;;R3 XLPE 0 Degree Liner;-At 1st postoperative year: 2.97% (0.97%-8.93%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 6.02% (2.75%-12.92%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 8.21% (4.18%-15.77%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 9.52% (5.05%-17.57%) vs 15.26% (14.87%-15.65%) of the class;-At 15th postoperative year: 12.44% (6.43%-23.32%) vs 18.82% (18.20%-19.46%) of the class;;R3 XLPE 20 Degree +4mm Lateralized Liner;-At 1st postoperative year: 7.77% (2.57%-22.2%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 15.91% (7.47%-32.06%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 19.02% (9.52%-35.92%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 19.02% (9.52%-35.92%) vs 15.26% (14.87%-15.65%) of the class;;R3 XLPE 20 Degree Hooded Liner;-At 1st postoperative year: 4.97% (3.66%-6.74%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 6.85% (5.28%-8.87%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 7.76% (6.06%-9.91%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 8.99% (7.09%-11.38%) vs 15.26% (14.87%-15.65%) of the class;-At 15th postoperative year: 11.1% (7.95%-15.38%) vs 18.82% (18.20%-19.46%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision:Wear of Acetabular Component.,85,Male,,3/31/2017,6/23/2020,E1614;E2401,F1905,A24;A051201,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L82,12/12/2024,7/21/2026,4/1/2026,R3 Acetabular system,R3 CONSTRAINED ACETABULAR LINER 54MM,71339154,23KM03388,71339154,,00885556020227,K211176,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of nine hundred sixty two (962) hips underwent revision THA procedures between 10-Sep-2008 and 20-Jan-2026, using an R3 XLPE Acetabular Liner. From these, one (1) hip was later re-revised due to:Loosening of socket, Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of nine hundred sixty two (962) hips underwent revision THA procedures between 10-Sep-2008 and 20-Jan-2026, using an R3 XLPE Acetabular Liner. From these, eighty nine (89) hips were later re-revised due to the following complications: twenty four (24) hips due to dislocation/subluxation, twenty three (23) hips due to infection, fifteen (15) hips due to aseptic loosening of the socket, eleven (11) hips due to periprosthetic fracture of the stem, ten (10) hips due to pain, eight (8) hips due to aseptic loosening of the stem, six (6) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to malalignment of the socket, two (2) hips due to other-unknown reasons, and two (2) hips due to wear of the acetabular component, and one (1) hip due to liner dissociation, one (1) hip due to peri prosthetic fracture, one (1) hip due to stem lysis, and one (1) hip due to periprosthetic fracture of the socket. It should be noted that more than one reason for revision may be listed for each revision surgery.; ;Timeframe of Registry Data: Implantations conducted between 10-Sep-2008 and 20-Jan-2026 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred sixty two (962) revision THA procedures with R3 XLPE Acetabular Liners have been performed in the United Kingdom between 10-Sep-2008 and 20-Jan-2026. ;;The mean cumulative re-revision rates for the R3 XLPE Acetabular Liners were in line or lower with the mean cumulative re-revision rates for the THA NJR class (22nd Annual report) across all years of follow-up data available. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;-At 1st postoperative year: 11.18% (2.91%-37.93%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 18.59% (6.28%-47.91%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 25.99% (10.44%-56.01%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 25.99% (10.44%-56.01%) vs 15.26% (14.87%-15.65%) of the class;;R3 XLPE 0 Degree Liner;-At 1st postoperative year: 2.97% (0.97%-8.93%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 6.02% (2.75%-12.92%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 8.21% (4.18%-15.77%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 9.52% (5.05%-17.57%) vs 15.26% (14.87%-15.65%) of the class;-At 15th postoperative year: 12.44% (6.43%-23.32%) vs 18.82% (18.20%-19.46%) of the class;;R3 XLPE 20 Degree +4mm Lateralized Liner;-At 1st postoperative year: 7.77% (2.57%-22.2%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 15.91% (7.47%-32.06%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 19.02% (9.52%-35.92%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 19.02% (9.52%-35.92%) vs 15.26% (14.87%-15.65%) of the class;;R3 XLPE 20 Degree Hooded Liner;-At 1st postoperative year: 4.97% (3.66%-6.74%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 6.85% (5.28%-8.87%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 7.76% (6.06%-9.91%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 8.99% (7.09%-11.38%) vs 15.26% (14.87%-15.65%) of the class;-At 15th postoperative year: 11.1% (7.95%-15.38%) vs 18.82% (18.20%-19.46%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.","Indication for first revision:Dislocation/Subluxation, Adverse Soft Tissue Reaction to Particulate Debris.",78,Female,,8/14/2024,12/12/2024,E161201;E1906,F1905,A0102;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L83,10/3/2019,7/21/2026,4/1/2026,R3 Acetabular system,R3 20 DEGREE XLPE ACETABULAR LINER 36MM X 66/70 OUTER DIAMETER,71331266,13EM17427,71331266,,00885556020692,K211176,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of nine hundred sixty two (962) hips underwent revision THA procedures between 10-Sep-2008 and 20-Jan-2026, using an R3 XLPE Acetabular Liner. From these, one (1) hip was later re-revised due to:Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of nine hundred sixty two (962) hips underwent revision THA procedures between 10-Sep-2008 and 20-Jan-2026, using an R3 XLPE Acetabular Liner. From these, eighty nine (89) hips were later re-revised due to the following complications: twenty four (24) hips due to dislocation/subluxation, twenty three (23) hips due to infection, fifteen (15) hips due to aseptic loosening of the socket, eleven (11) hips due to periprosthetic fracture of the stem, ten (10) hips due to pain, eight (8) hips due to aseptic loosening of the stem, six (6) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to malalignment of the socket, two (2) hips due to other-unknown reasons, and two (2) hips due to wear of the acetabular component, and one (1) hip due to liner dissociation, one (1) hip due to peri prosthetic fracture, one (1) hip due to stem lysis, and one (1) hip due to periprosthetic fracture of the socket. It should be noted that more than one reason for revision may be listed for each revision surgery.; ;Timeframe of Registry Data: Implantations conducted between 10-Sep-2008 and 20-Jan-2026 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred sixty two (962) revision THA procedures with R3 XLPE Acetabular Liners have been performed in the United Kingdom between 10-Sep-2008 and 20-Jan-2026. ;;The mean cumulative re-revision rates for the R3 XLPE Acetabular Liners were in line or lower with the mean cumulative re-revision rates for the THA NJR class (22nd Annual report) across all years of follow-up data available. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;-At 1st postoperative year: 11.18% (2.91%-37.93%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 18.59% (6.28%-47.91%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 25.99% (10.44%-56.01%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 25.99% (10.44%-56.01%) vs 15.26% (14.87%-15.65%) of the class;;R3 XLPE 0 Degree Liner;-At 1st postoperative year: 2.97% (0.97%-8.93%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 6.02% (2.75%-12.92%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 8.21% (4.18%-15.77%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 9.52% (5.05%-17.57%) vs 15.26% (14.87%-15.65%) of the class;-At 15th postoperative year: 12.44% (6.43%-23.32%) vs 18.82% (18.20%-19.46%) of the class;;R3 XLPE 20 Degree +4mm Lateralized Liner;-At 1st postoperative year: 7.77% (2.57%-22.2%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 15.91% (7.47%-32.06%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 19.02% (9.52%-35.92%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 19.02% (9.52%-35.92%) vs 15.26% (14.87%-15.65%) of the class;;R3 XLPE 20 Degree Hooded Liner;-At 1st postoperative year: 4.97% (3.66%-6.74%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 6.85% (5.28%-8.87%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 7.76% (6.06%-9.91%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 8.99% (7.09%-11.38%) vs 15.26% (14.87%-15.65%) of the class;-At 15th postoperative year: 11.1% (7.95%-15.38%) vs 18.82% (18.20%-19.46%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision:Lysis of Stem.,58,Male,115,8/22/2017,10/3/2019,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L84,3/2/2022,7/21/2026,4/1/2026,R3 Acetabular system,R3 20 DEGREE XLPE ACETABULAR LINER 36MM X 66/70 OUTER DIAMETER,71331266,21cm22062,71331266,,00885556020692,K211176,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of nine hundred sixty two (962) hips underwent revision THA procedures between 10-Sep-2008 and 20-Jan-2026, using an R3 XLPE Acetabular Liner. From these, one (1) hip was later re-revised due to:Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of nine hundred sixty two (962) hips underwent revision THA procedures between 10-Sep-2008 and 20-Jan-2026, using an R3 XLPE Acetabular Liner. From these, eighty nine (89) hips were later re-revised due to the following complications: twenty four (24) hips due to dislocation/subluxation, twenty three (23) hips due to infection, fifteen (15) hips due to aseptic loosening of the socket, eleven (11) hips due to periprosthetic fracture of the stem, ten (10) hips due to pain, eight (8) hips due to aseptic loosening of the stem, six (6) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to malalignment of the socket, two (2) hips due to other-unknown reasons, and two (2) hips due to wear of the acetabular component, and one (1) hip due to liner dissociation, one (1) hip due to peri prosthetic fracture, one (1) hip due to stem lysis, and one (1) hip due to periprosthetic fracture of the socket. It should be noted that more than one reason for revision may be listed for each revision surgery.; ;Timeframe of Registry Data: Implantations conducted between 10-Sep-2008 and 20-Jan-2026 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred sixty two (962) revision THA procedures with R3 XLPE Acetabular Liners have been performed in the United Kingdom between 10-Sep-2008 and 20-Jan-2026. ;;The mean cumulative re-revision rates for the R3 XLPE Acetabular Liners were in line or lower with the mean cumulative re-revision rates for the THA NJR class (22nd Annual report) across all years of follow-up data available. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;-At 1st postoperative year: 11.18% (2.91%-37.93%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 18.59% (6.28%-47.91%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 25.99% (10.44%-56.01%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 25.99% (10.44%-56.01%) vs 15.26% (14.87%-15.65%) of the class;;R3 XLPE 0 Degree Liner;-At 1st postoperative year: 2.97% (0.97%-8.93%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 6.02% (2.75%-12.92%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 8.21% (4.18%-15.77%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 9.52% (5.05%-17.57%) vs 15.26% (14.87%-15.65%) of the class;-At 15th postoperative year: 12.44% (6.43%-23.32%) vs 18.82% (18.20%-19.46%) of the class;;R3 XLPE 20 Degree +4mm Lateralized Liner;-At 1st postoperative year: 7.77% (2.57%-22.2%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 15.91% (7.47%-32.06%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 19.02% (9.52%-35.92%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 19.02% (9.52%-35.92%) vs 15.26% (14.87%-15.65%) of the class;;R3 XLPE 20 Degree Hooded Liner;-At 1st postoperative year: 4.97% (3.66%-6.74%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 6.85% (5.28%-8.87%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 7.76% (6.06%-9.91%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 8.99% (7.09%-11.38%) vs 15.26% (14.87%-15.65%) of the class;-At 15th postoperative year: 11.1% (7.95%-15.38%) vs 18.82% (18.20%-19.46%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision:Loosening of socket.,85,Male,71,8/18/2021,3/2/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L85,2/6/2024,7/21/2026,4/1/2026,R3 Acetabular system,R3 20 DEGREE XLPE ACETABULAR LINER 36MM X 66/70 OUTER DIAMETER,71331266,14BM786,71331266,,00885556020692,K211176,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of nine hundred sixty two (962) hips underwent revision THA procedures between 10-Sep-2008 and 20-Jan-2026, using an R3 XLPE Acetabular Liner. From these, one (1) hip was later re-revised due to:Infection, Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of nine hundred sixty two (962) hips underwent revision THA procedures between 10-Sep-2008 and 20-Jan-2026, using an R3 XLPE Acetabular Liner. From these, eighty nine (89) hips were later re-revised due to the following complications: twenty four (24) hips due to dislocation/subluxation, twenty three (23) hips due to infection, fifteen (15) hips due to aseptic loosening of the socket, eleven (11) hips due to periprosthetic fracture of the stem, ten (10) hips due to pain, eight (8) hips due to aseptic loosening of the stem, six (6) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to malalignment of the socket, two (2) hips due to other-unknown reasons, and two (2) hips due to wear of the acetabular component, and one (1) hip due to liner dissociation, one (1) hip due to peri prosthetic fracture, one (1) hip due to stem lysis, and one (1) hip due to periprosthetic fracture of the socket. It should be noted that more than one reason for revision may be listed for each revision surgery.; ;Timeframe of Registry Data: Implantations conducted between 10-Sep-2008 and 20-Jan-2026 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred sixty two (962) revision THA procedures with R3 XLPE Acetabular Liners have been performed in the United Kingdom between 10-Sep-2008 and 20-Jan-2026. ;;The mean cumulative re-revision rates for the R3 XLPE Acetabular Liners were in line or lower with the mean cumulative re-revision rates for the THA NJR class (22nd Annual report) across all years of follow-up data available. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;-At 1st postoperative year: 11.18% (2.91%-37.93%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 18.59% (6.28%-47.91%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 25.99% (10.44%-56.01%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 25.99% (10.44%-56.01%) vs 15.26% (14.87%-15.65%) of the class;;R3 XLPE 0 Degree Liner;-At 1st postoperative year: 2.97% (0.97%-8.93%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 6.02% (2.75%-12.92%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 8.21% (4.18%-15.77%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 9.52% (5.05%-17.57%) vs 15.26% (14.87%-15.65%) of the class;-At 15th postoperative year: 12.44% (6.43%-23.32%) vs 18.82% (18.20%-19.46%) of the class;;R3 XLPE 20 Degree +4mm Lateralized Liner;-At 1st postoperative year: 7.77% (2.57%-22.2%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 15.91% (7.47%-32.06%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 19.02% (9.52%-35.92%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 19.02% (9.52%-35.92%) vs 15.26% (14.87%-15.65%) of the class;;R3 XLPE 20 Degree Hooded Liner;-At 1st postoperative year: 4.97% (3.66%-6.74%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 6.85% (5.28%-8.87%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 7.76% (6.06%-9.91%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 8.99% (7.09%-11.38%) vs 15.26% (14.87%-15.65%) of the class;-At 15th postoperative year: 11.1% (7.95%-15.38%) vs 18.82% (18.20%-19.46%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision:Infection.,69,Male,133,4/11/2023,2/6/2024,E2127;E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L86,12/17/2025,7/21/2026,4/1/2026,R3 Acetabular system,R3 20 DEGREE XLPE ACETABULAR LINER 28MM INNER DIAMETER X OUTER DIAMETER 58MM,71334958,08CM01380,71334958,,03596010598158,K113848,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of nine hundred sixty two (962) hips underwent revision THA procedures between 10-Sep-2008 and 20-Jan-2026, using an R3 XLPE Acetabular Liner. From these, one (1) hip was later re-revised due to:Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of nine hundred sixty two (962) hips underwent revision THA procedures between 10-Sep-2008 and 20-Jan-2026, using an R3 XLPE Acetabular Liner. From these, eighty nine (89) hips were later re-revised due to the following complications: twenty four (24) hips due to dislocation/subluxation, twenty three (23) hips due to infection, fifteen (15) hips due to aseptic loosening of the socket, eleven (11) hips due to periprosthetic fracture of the stem, ten (10) hips due to pain, eight (8) hips due to aseptic loosening of the stem, six (6) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to malalignment of the socket, two (2) hips due to other-unknown reasons, and two (2) hips due to wear of the acetabular component, and one (1) hip due to liner dissociation, one (1) hip due to peri prosthetic fracture, one (1) hip due to stem lysis, and one (1) hip due to periprosthetic fracture of the socket. It should be noted that more than one reason for revision may be listed for each revision surgery.; ;Timeframe of Registry Data: Implantations conducted between 10-Sep-2008 and 20-Jan-2026 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred sixty two (962) revision THA procedures with R3 XLPE Acetabular Liners have been performed in the United Kingdom between 10-Sep-2008 and 20-Jan-2026. ;;The mean cumulative re-revision rates for the R3 XLPE Acetabular Liners were in line or lower with the mean cumulative re-revision rates for the THA NJR class (22nd Annual report) across all years of follow-up data available. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;-At 1st postoperative year: 11.18% (2.91%-37.93%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 18.59% (6.28%-47.91%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 25.99% (10.44%-56.01%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 25.99% (10.44%-56.01%) vs 15.26% (14.87%-15.65%) of the class;;R3 XLPE 0 Degree Liner;-At 1st postoperative year: 2.97% (0.97%-8.93%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 6.02% (2.75%-12.92%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 8.21% (4.18%-15.77%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 9.52% (5.05%-17.57%) vs 15.26% (14.87%-15.65%) of the class;-At 15th postoperative year: 12.44% (6.43%-23.32%) vs 18.82% (18.20%-19.46%) of the class;;R3 XLPE 20 Degree +4mm Lateralized Liner;-At 1st postoperative year: 7.77% (2.57%-22.2%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 15.91% (7.47%-32.06%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 19.02% (9.52%-35.92%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 19.02% (9.52%-35.92%) vs 15.26% (14.87%-15.65%) of the class;;R3 XLPE 20 Degree Hooded Liner;-At 1st postoperative year: 4.97% (3.66%-6.74%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 6.85% (5.28%-8.87%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 7.76% (6.06%-9.91%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 8.99% (7.09%-11.38%) vs 15.26% (14.87%-15.65%) of the class;-At 15th postoperative year: 11.1% (7.95%-15.38%) vs 18.82% (18.20%-19.46%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision:Infection.,49,Female,,9/22/2008,12/17/2025,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L87,6/13/2025,7/21/2026,4/1/2026,R3 Acetabular system,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 60MM,71335760,10LM13031,71335760,,03596010598370,K113848,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of nine hundred sixty two (962) hips underwent revision THA procedures between 10-Sep-2008 and 20-Jan-2026, using an R3 XLPE Acetabular Liner. From these, one (1) hip was later re-revised due to:Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of nine hundred sixty two (962) hips underwent revision THA procedures between 10-Sep-2008 and 20-Jan-2026, using an R3 XLPE Acetabular Liner. From these, eighty nine (89) hips were later re-revised due to the following complications: twenty four (24) hips due to dislocation/subluxation, twenty three (23) hips due to infection, fifteen (15) hips due to aseptic loosening of the socket, eleven (11) hips due to periprosthetic fracture of the stem, ten (10) hips due to pain, eight (8) hips due to aseptic loosening of the stem, six (6) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to malalignment of the socket, two (2) hips due to other-unknown reasons, and two (2) hips due to wear of the acetabular component, and one (1) hip due to liner dissociation, one (1) hip due to peri prosthetic fracture, one (1) hip due to stem lysis, and one (1) hip due to periprosthetic fracture of the socket. It should be noted that more than one reason for revision may be listed for each revision surgery.; ;Timeframe of Registry Data: Implantations conducted between 10-Sep-2008 and 20-Jan-2026 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred sixty two (962) revision THA procedures with R3 XLPE Acetabular Liners have been performed in the United Kingdom between 10-Sep-2008 and 20-Jan-2026. ;;The mean cumulative re-revision rates for the R3 XLPE Acetabular Liners were in line or lower with the mean cumulative re-revision rates for the THA NJR class (22nd Annual report) across all years of follow-up data available. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;-At 1st postoperative year: 11.18% (2.91%-37.93%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 18.59% (6.28%-47.91%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 25.99% (10.44%-56.01%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 25.99% (10.44%-56.01%) vs 15.26% (14.87%-15.65%) of the class;;R3 XLPE 0 Degree Liner;-At 1st postoperative year: 2.97% (0.97%-8.93%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 6.02% (2.75%-12.92%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 8.21% (4.18%-15.77%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 9.52% (5.05%-17.57%) vs 15.26% (14.87%-15.65%) of the class;-At 15th postoperative year: 12.44% (6.43%-23.32%) vs 18.82% (18.20%-19.46%) of the class;;R3 XLPE 20 Degree +4mm Lateralized Liner;-At 1st postoperative year: 7.77% (2.57%-22.2%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 15.91% (7.47%-32.06%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 19.02% (9.52%-35.92%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 19.02% (9.52%-35.92%) vs 15.26% (14.87%-15.65%) of the class;;R3 XLPE 20 Degree Hooded Liner;-At 1st postoperative year: 4.97% (3.66%-6.74%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 6.85% (5.28%-8.87%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 7.76% (6.06%-9.91%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 8.99% (7.09%-11.38%) vs 15.26% (14.87%-15.65%) of the class;-At 15th postoperative year: 11.1% (7.95%-15.38%) vs 18.82% (18.20%-19.46%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision:Unexplained Pain.,79,Male,,9/6/2011,6/13/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L88,3/10/2025,7/21/2026,4/1/2026,R3 Acetabular system,R3 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 60MM,71335760,22jm18187,71335760,,03596010598370,K113848,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of nine hundred sixty two (962) hips underwent revision THA procedures between 10-Sep-2008 and 20-Jan-2026, using an R3 XLPE Acetabular Liner. From these, one (1) hip was later re-revised due to:Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of nine hundred sixty two (962) hips underwent revision THA procedures between 10-Sep-2008 and 20-Jan-2026, using an R3 XLPE Acetabular Liner. From these, eighty nine (89) hips were later re-revised due to the following complications: twenty four (24) hips due to dislocation/subluxation, twenty three (23) hips due to infection, fifteen (15) hips due to aseptic loosening of the socket, eleven (11) hips due to periprosthetic fracture of the stem, ten (10) hips due to pain, eight (8) hips due to aseptic loosening of the stem, six (6) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to malalignment of the socket, two (2) hips due to other-unknown reasons, and two (2) hips due to wear of the acetabular component, and one (1) hip due to liner dissociation, one (1) hip due to peri prosthetic fracture, one (1) hip due to stem lysis, and one (1) hip due to periprosthetic fracture of the socket. It should be noted that more than one reason for revision may be listed for each revision surgery.; ;Timeframe of Registry Data: Implantations conducted between 10-Sep-2008 and 20-Jan-2026 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred sixty two (962) revision THA procedures with R3 XLPE Acetabular Liners have been performed in the United Kingdom between 10-Sep-2008 and 20-Jan-2026. ;;The mean cumulative re-revision rates for the R3 XLPE Acetabular Liners were in line or lower with the mean cumulative re-revision rates for the THA NJR class (22nd Annual report) across all years of follow-up data available. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;-At 1st postoperative year: 11.18% (2.91%-37.93%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 18.59% (6.28%-47.91%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 25.99% (10.44%-56.01%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 25.99% (10.44%-56.01%) vs 15.26% (14.87%-15.65%) of the class;;R3 XLPE 0 Degree Liner;-At 1st postoperative year: 2.97% (0.97%-8.93%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 6.02% (2.75%-12.92%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 8.21% (4.18%-15.77%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 9.52% (5.05%-17.57%) vs 15.26% (14.87%-15.65%) of the class;-At 15th postoperative year: 12.44% (6.43%-23.32%) vs 18.82% (18.20%-19.46%) of the class;;R3 XLPE 20 Degree +4mm Lateralized Liner;-At 1st postoperative year: 7.77% (2.57%-22.2%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 15.91% (7.47%-32.06%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 19.02% (9.52%-35.92%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 19.02% (9.52%-35.92%) vs 15.26% (14.87%-15.65%) of the class;;R3 XLPE 20 Degree Hooded Liner;-At 1st postoperative year: 4.97% (3.66%-6.74%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 6.85% (5.28%-8.87%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 7.76% (6.06%-9.91%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 8.99% (7.09%-11.38%) vs 15.26% (14.87%-15.65%) of the class;-At 15th postoperative year: 11.1% (7.95%-15.38%) vs 18.82% (18.20%-19.46%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision:Infection.,38,Male,77,4/19/2023,3/10/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00267330-1-L89,7/11/2025,7/21/2026,4/1/2026,R3 Acetabular system,R3 20 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 56MM,71335756,23hm17213,71335756,,03596010598356,K113848,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of nine hundred sixty two (962) hips underwent revision THA procedures between 10-Sep-2008 and 20-Jan-2026, using an R3 XLPE Acetabular Liner. From these, one (1) hip was later re-revised due to:Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of nine hundred sixty two (962) hips underwent revision THA procedures between 10-Sep-2008 and 20-Jan-2026, using an R3 XLPE Acetabular Liner. From these, eighty nine (89) hips were later re-revised due to the following complications: twenty four (24) hips due to dislocation/subluxation, twenty three (23) hips due to infection, fifteen (15) hips due to aseptic loosening of the socket, eleven (11) hips due to periprosthetic fracture of the stem, ten (10) hips due to pain, eight (8) hips due to aseptic loosening of the stem, six (6) hips due to adverse soft tissue reaction to particle debris, two (2) hips due to malalignment of the socket, two (2) hips due to other-unknown reasons, and two (2) hips due to wear of the acetabular component, and one (1) hip due to liner dissociation, one (1) hip due to peri prosthetic fracture, one (1) hip due to stem lysis, and one (1) hip due to periprosthetic fracture of the socket. It should be noted that more than one reason for revision may be listed for each revision surgery.; ;Timeframe of Registry Data: Implantations conducted between 10-Sep-2008 and 20-Jan-2026 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the R3 Acetabular system presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of nine hundred sixty two (962) revision THA procedures with R3 XLPE Acetabular Liners have been performed in the United Kingdom between 10-Sep-2008 and 20-Jan-2026. ;;The mean cumulative re-revision rates for the R3 XLPE Acetabular Liners were in line or lower with the mean cumulative re-revision rates for the THA NJR class (22nd Annual report) across all years of follow-up data available. ;;The following cumulative re-revision rates with 95% confidence intervals are presented in this report: ;R3 XLPE Constrained Liner;-At 1st postoperative year: 11.18% (2.91%-37.93%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 18.59% (6.28%-47.91%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 25.99% (10.44%-56.01%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 25.99% (10.44%-56.01%) vs 15.26% (14.87%-15.65%) of the class;;R3 XLPE 0 Degree Liner;-At 1st postoperative year: 2.97% (0.97%-8.93%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 6.02% (2.75%-12.92%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 8.21% (4.18%-15.77%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 9.52% (5.05%-17.57%) vs 15.26% (14.87%-15.65%) of the class;-At 15th postoperative year: 12.44% (6.43%-23.32%) vs 18.82% (18.20%-19.46%) of the class;;R3 XLPE 20 Degree +4mm Lateralized Liner;-At 1st postoperative year: 7.77% (2.57%-22.2%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 15.91% (7.47%-32.06%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 19.02% (9.52%-35.92%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 19.02% (9.52%-35.92%) vs 15.26% (14.87%-15.65%) of the class;;R3 XLPE 20 Degree Hooded Liner;-At 1st postoperative year: 4.97% (3.66%-6.74%) vs 5.74% (5.54%-5.95%) of the class;-At 3rd postoperative year: 6.85% (5.28%-8.87%) vs 9.51% (9.24%-9.78%) of the class;-At 5th postoperative year: 7.76% (6.06%-9.91%) vs 11.55% (11.25%-11.85%) of the class;-At 10th postoperative year: 8.99% (7.09%-11.38%) vs 15.26% (14.87%-15.65%) of the class;-At 15th postoperative year: 11.1% (7.95%-15.38%) vs 18.82% (18.20%-19.46%) of the class;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision:Infection.,81,Male,86,6/27/2025,7/11/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272916-1-L7,5/21/2025,7/21/2026,6/5/2026,REFLECTION XLPE All-Poly Cup,REF ALL POLY 28ID 49OD XLPE,71358024,18LT13382,71358024,,03596010481795,K002747,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of fifty-four (54) hips underwent revision THR between 23-Jan-2007 and 10-Apr-2026 in which a REFLECTION All-Poly XLPE Cup was implanted. Of these, one (1) hip was re-revised due to loosening of the socket.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of fifty-four (54) hips underwent revision THR between 23-Jan-2007 and 10-Apr-2026 in which a REFLECTION All-Poly XLPE Cup was implanted. Of these, eight (8) hips required re-revision due to the following reasons: three (3) hips due to infection, two (2) due to pain, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to aseptic loosening of the socket, one (1) due to lysis of the socket, one (1) due to lysis of the stem, one (1) due to periprosthetic fracture of the stem, one (1) due to wear of the acetabular component, and one (1) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 23-Jan-2007 and 10-Apr-2026 in United Kingdom;;Analysis Conducted: ;Based on the most recent safety and performance evaluation, the REFLECTION All-Poly XLPE Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of fifty-four (54) hips underwent revision THR in which a REFLECTION All-Poly XLPE Cup was implanted in United Kingdom between 23-Jan-2007 and 10-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; At 1st postoperative year: 5.78% (1.9%-16.87%) vs 5.95% (5.53%-6.40%) of the class; At 3rd postoperative year: 10.32% (4.41%-23.14%) vs 9.48% (8.93%-10.06%) of the class; At 5th postoperative year: 18.09% (9.39%-33.21%) vs 11.29% (10.67%-11.94%) of the class; At 7th postoperative year: 18.09% (9.39%-33.21%) vs 12.83% (12.14%-13.56%) of the class; At 10th postoperative year: 18.09% (9.39%-33.21%) vs 15.20% (14.34%-16.11%) of the class; At 15th postoperative year: 18.09% (9.39%-33.21%) vs 18.03% (16.68%-19.47%) of the class;By observing the cumulative re-revision rates above, it can be determined that there is no statistically significant difference between the re-revision rates of the REFLECTION All-Poly XLPE Cup and the revision THR class, as determined by overlapping 95% confidence intervals across all evaluated postoperative years.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Lysis ¿ Stem/Lysis ¿ Socket/Infection,67,Female,68,8/25/2021,5/21/2025,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00272916-1-L8,9/8/2025,7/21/2026,6/5/2026,REFLECTION XLPE All-Poly Cup,REF XLPE ALL PLY CUP 36 52,71358065,24ET82422,71358065,,03596010533173,K002747,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of fifty-four (54) hips underwent revision THR between 23-Jan-2007 and 10-Apr-2026 in which a REFLECTION All-Poly XLPE Cup was implanted. Of these, one (1) hip was re-revised due to loosening of the infection.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of fifty-four (54) hips underwent revision THR between 23-Jan-2007 and 10-Apr-2026 in which a REFLECTION All-Poly XLPE Cup was implanted. Of these, eight (8) hips required re-revision due to the following reasons: three (3) hips due to infection, two (2) due to pain, one (1) due to adverse soft tissue reaction to particle debris, one (1) due to aseptic loosening of the socket, one (1) due to lysis of the socket, one (1) due to lysis of the stem, one (1) due to periprosthetic fracture of the stem, one (1) due to wear of the acetabular component, and one (1) due to other reasons. Multiple reasons for revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 23-Jan-2007 and 10-Apr-2026 in United Kingdom;;Analysis Conducted: ;Based on the most recent safety and performance evaluation, the REFLECTION All-Poly XLPE Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of fifty-four (54) hips underwent revision THR in which a REFLECTION All-Poly XLPE Cup was implanted in United Kingdom between 23-Jan-2007 and 10-Apr-2026. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; At 1st postoperative year: 5.78% (1.9%-16.87%) vs 5.95% (5.53%-6.40%) of the class; At 3rd postoperative year: 10.32% (4.41%-23.14%) vs 9.48% (8.93%-10.06%) of the class; At 5th postoperative year: 18.09% (9.39%-33.21%) vs 11.29% (10.67%-11.94%) of the class; At 7th postoperative year: 18.09% (9.39%-33.21%) vs 12.83% (12.14%-13.56%) of the class; At 10th postoperative year: 18.09% (9.39%-33.21%) vs 15.20% (14.34%-16.11%) of the class; At 15th postoperative year: 18.09% (9.39%-33.21%) vs 18.03% (16.68%-19.47%) of the class;By observing the cumulative re-revision rates above, it can be determined that there is no statistically significant difference between the re-revision rates of the REFLECTION All-Poly XLPE Cup and the revision THR class, as determined by overlapping 95% confidence intervals across all evaluated postoperative years.;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for first revision: Infection,76,Female,,4/23/2025,9/8/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15, ,0;CASE-2025-00269427-1-L28,8/25/2025,7/21/2026,5/19/2026,REFLECTION Acetabular System,REFLECTION XLPE 32mm Inner Diameter 20 Degree 58-60mm Outer Diameter Size G,71333336,06lm09043,71333336,,03596010455697,K002747,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of one hundred and ninety-two (192) hips underwent revision THA procedures between 06-Oct-2004 and 09-Mar-2015, using a REFLECTION XLPE Acetabular Liner. Of these, one (1) hip was later re-revised due to Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);;Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of one hundred and ninety-two (192) hips underwent revision THA between 06-Oct-2004 and 09-Mar-2015 in which a REFLECTION XLPE Acetabular Liner was implanted. Of these, twenty-eight (28) hips required re-revision due to the following reasons: eight (8) hips due to infection, six (6) hips due to dislocation/subluxation, four (4) hips due to pain, three (3) hips due to aseptic loosening associated with the socket, three (3) hips due to aseptic loosening associated with the stem, three (3) hips due to implant fracture associated with the femoral stem, two (2) hips due to other/unknown reasons, one (1) hip due to periprosthetic fracture associated with the socket, one (1) hip due to periprosthetic fracture associated with the stem, and one (1) hip due to an unspecified periprosthetic fracture. Multiple reasons for re-revision may be listed for a single procedure.;Timeframe of Registry Data: Implantations conducted between 06-Oct-2004 and 09-Mar-2015 in United Kingdom;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION Acetabular System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of one hundred and ninety-two (192) hips underwent revision THA in which a REFLECTION XLPE Acetabular Liner was implanted in United Kingdom between 06-Oct-2004 and 09-Mar-2015. The following cumulative revision rates with 95% confidence intervals are presented in this report: ; At 1st post-operative year: 4.19% (2.12%-8.2%) vs 5.66% (5.45%-5.88%) of the class; At 3rd post-operative year: 7.41% (4.46%-12.19%) vs 9.48% (9.20%-9.76%) of the class; At 5th post-operative year: 7.96% (4.88%-12.87%) vs 11.53% (11.22%-11.85%) of the class; At 10th post-operative year: 10.51% (6.82%-16.03%) vs 15.23% (14.83%-15.64%) of the class; At 15th post-operative year: 16.88% (11.61%-24.19%) vs 19.03% (18.31%-19.78%) of the class;;By observing the cumulative re-revision rates above, it can be determined that there is no statistically significant difference between the re-revision rates of the REFLECTION XLPE Acetabular Liner and the revision THA class, as determined by overlapping 95% confidence intervals throughout the 15 follow-up years.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for 1st revision procedure: Dislocation/Subluxation,78,Female,53,1/11/2008,8/25/2025,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L57,5/22/2025,7/21/2026,6/5/2026,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 49OD XLPE,71358034,19JT27443,71358034,,03596010474247,K002747,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand four hundred forty-nine (3,449) hips underwent primary THA procedures between 13-Sep-2006 and 23-Mar-2026, using a REFLECTION XLPE All-Poly cup. Of these, one (1) hip was later revised due to Malalignment of Socket, Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand four hundred forty-nine (3,449) hips underwent primary THA procedures between 13-Sep-2006 and 23-Mar-2026, using a REFLECTION XLPE All-Poly cup. Of these, sixty (60) hips were later revised due to the following reasons: nineteen (19) hips due to periprosthetic fracture of the stem, fifteen (15) hips due to infection, fourteen (14) hips due to dislocation/subluxation, ten (10) hips due to aseptic loosening of the socket, five (5) hips due to aseptic loosening of the stem, five (5) hips due to malalignment of the socket, three (3) hips due to wear of the acetabular component, two (2) hips due to lysis of the socket, two (2) hips due to malalignment of the stem, two (2) hips due to other-unknown reasons, and two (2) hips due to periprosthetic fracture of the socket, and one (1) hip due to adverse soft tissue reaction to particle debris, one (1) hip due to implant fracture of the ceramic component of the stem, one (1) hip due to lysis of the stem, and one (1) hip due to pain. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry Data: Implantations conducted between 13-Sep-2006 and 23-Mar-2026 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of three thousand four hundred forty-nine (3,449) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 23-Mar-2026. At all time points from 1 to 18 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line or below with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.68% (0.45%-1.02%) vs 0.77% (0.76%-0.78%) of the class.;-At 3rd postoperative year: 1.07% (0.77%-1.48%) vs 1.35% (1.34%-1.37%) of the class.;-At 5th postoperative year: 1.62% (1.22%-2.16%) vs 1.90% (1.88%-1.92%) of the class.;-At 7th postoperative year: 2.18% (1.67%-2.86%) vs 2.49% (2.46%-2.52%) of the class.;-At 10th postoperative year: 2.37% (1.81%-3.11%) vs 3.47% (3.44%-3.50%) of the class.;-At 15th postoperative year: 2.6% (1.92%-3.52%) vs 5.56% (5.51%-5.62%) of the class.;-At 18th postoperative year: 2.6% (1.92%-3.52%) vs 7.07% (6.98%-7.15%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,86,Female,,12/13/2019,5/22/2025,E1614;E2308,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L58,10/16/2025,7/21/2026,6/5/2026,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 49OD XLPE,71358034,20HT40865,71358034,,03596010474247,K002747,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand four hundred forty-nine (3,449) hips underwent primary THA procedures between 13-Sep-2006 and 23-Mar-2026, using a REFLECTION XLPE All-Poly cup. Of these, one (1) hip was later revised due to Looseningof stem, Implant Fracture of a ceramic component of Stem.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand four hundred forty-nine (3,449) hips underwent primary THA procedures between 13-Sep-2006 and 23-Mar-2026, using a REFLECTION XLPE All-Poly cup. Of these, sixty (60) hips were later revised due to the following reasons: nineteen (19) hips due to periprosthetic fracture of the stem, fifteen (15) hips due to infection, fourteen (14) hips due to dislocation/subluxation, ten (10) hips due to aseptic loosening of the socket, five (5) hips due to aseptic loosening of the stem, five (5) hips due to malalignment of the socket, three (3) hips due to wear of the acetabular component, two (2) hips due to lysis of the socket, two (2) hips due to malalignment of the stem, two (2) hips due to other-unknown reasons, and two (2) hips due to periprosthetic fracture of the socket, and one (1) hip due to adverse soft tissue reaction to particle debris, one (1) hip due to implant fracture of the ceramic component of the stem, one (1) hip due to lysis of the stem, and one (1) hip due to pain. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry Data: Implantations conducted between 13-Sep-2006 and 23-Mar-2026 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of three thousand four hundred forty-nine (3,449) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 23-Mar-2026. At all time points from 1 to 18 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line or below with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.68% (0.45%-1.02%) vs 0.77% (0.76%-0.78%) of the class.;-At 3rd postoperative year: 1.07% (0.77%-1.48%) vs 1.35% (1.34%-1.37%) of the class.;-At 5th postoperative year: 1.62% (1.22%-2.16%) vs 1.90% (1.88%-1.92%) of the class.;-At 7th postoperative year: 2.18% (1.67%-2.86%) vs 2.49% (2.46%-2.52%) of the class.;-At 10th postoperative year: 2.37% (1.81%-3.11%) vs 3.47% (3.44%-3.50%) of the class.;-At 15th postoperative year: 2.6% (1.92%-3.52%) vs 5.56% (5.51%-5.62%) of the class.;-At 18th postoperative year: 2.6% (1.92%-3.52%) vs 7.07% (6.98%-7.15%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,88,Female,,5/28/2021,,E161201;E2401,F1905,A0102;A040101,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L59,6/12/2025,7/21/2026,6/5/2026,REFLECTION XLPE All-Poly Cup,REF ALL POLY 32ID 49OD XLPE,71358034,19LT30874,71358034,,03596010474247,K002747,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand four hundred forty-nine (3,449) hips underwent primary THA procedures between 13-Sep-2006 and 23-Mar-2026, using a REFLECTION XLPE All-Poly cup. Of these, one (1) hip was later revised due to Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand four hundred forty-nine (3,449) hips underwent primary THA procedures between 13-Sep-2006 and 23-Mar-2026, using a REFLECTION XLPE All-Poly cup. Of these, sixty (60) hips were later revised due to the following reasons: nineteen (19) hips due to periprosthetic fracture of the stem, fifteen (15) hips due to infection, fourteen (14) hips due to dislocation/subluxation, ten (10) hips due to aseptic loosening of the socket, five (5) hips due to aseptic loosening of the stem, five (5) hips due to malalignment of the socket, three (3) hips due to wear of the acetabular component, two (2) hips due to lysis of the socket, two (2) hips due to malalignment of the stem, two (2) hips due to other-unknown reasons, and two (2) hips due to periprosthetic fracture of the socket, and one (1) hip due to adverse soft tissue reaction to particle debris, one (1) hip due to implant fracture of the ceramic component of the stem, one (1) hip due to lysis of the stem, and one (1) hip due to pain. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry Data: Implantations conducted between 13-Sep-2006 and 23-Mar-2026 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of three thousand four hundred forty-nine (3,449) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 23-Mar-2026. At all time points from 1 to 18 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line or below with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.68% (0.45%-1.02%) vs 0.77% (0.76%-0.78%) of the class.;-At 3rd postoperative year: 1.07% (0.77%-1.48%) vs 1.35% (1.34%-1.37%) of the class.;-At 5th postoperative year: 1.62% (1.22%-2.16%) vs 1.90% (1.88%-1.92%) of the class.;-At 7th postoperative year: 2.18% (1.67%-2.86%) vs 2.49% (2.46%-2.52%) of the class.;-At 10th postoperative year: 2.37% (1.81%-3.11%) vs 3.47% (3.44%-3.50%) of the class.;-At 15th postoperative year: 2.6% (1.92%-3.52%) vs 5.56% (5.51%-5.62%) of the class.;-At 18th postoperative year: 2.6% (1.92%-3.52%) vs 7.07% (6.98%-7.15%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,78,Female,,8/9/2021,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00272890-1-L60,7/12/2025,7/21/2026,6/5/2026,REFLECTION XLPE All-Poly Cup,REF XLPE ALL PLY CUP 36 52,71358065,23jt76987,71358065,,03596010533173,K002747,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand four hundred forty-nine (3,449) hips underwent primary THA procedures between 13-Sep-2006 and 23-Mar-2026, using a REFLECTION XLPE All-Poly cup. Of these, one (1) hip was later revised due to Dislocation/Subluxation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of three thousand four hundred forty-nine (3,449) hips underwent primary THA procedures between 13-Sep-2006 and 23-Mar-2026, using a REFLECTION XLPE All-Poly cup. Of these, sixty (60) hips were later revised due to the following reasons: nineteen (19) hips due to periprosthetic fracture of the stem, fifteen (15) hips due to infection, fourteen (14) hips due to dislocation/subluxation, ten (10) hips due to aseptic loosening of the socket, five (5) hips due to aseptic loosening of the stem, five (5) hips due to malalignment of the socket, three (3) hips due to wear of the acetabular component, two (2) hips due to lysis of the socket, two (2) hips due to malalignment of the stem, two (2) hips due to other-unknown reasons, and two (2) hips due to periprosthetic fracture of the socket, and one (1) hip due to adverse soft tissue reaction to particle debris, one (1) hip due to implant fracture of the ceramic component of the stem, one (1) hip due to lysis of the stem, and one (1) hip due to pain. It should be noted that more than one reason for revision may be listed for each revision procedure.;Timeframe of Registry Data: Implantations conducted between 13-Sep-2006 and 23-Mar-2026 in the United Kingdom.;;Analysis Conducted: Based on the most recent safety and performance evaluation, the REFLECTION XLPE All-Poly Cup presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;;According to this registry report, a total of three thousand four hundred forty-nine (3,449) THA primary procedures with REFLECTION XLPE All-Poly cups have been performed in the United Kingdom between 13-Sep-2006 and 23-Mar-2026. At all time points from 1 to 18 follow-up years, the Kaplan-Meier revision rate of the REFLECTION All-Poly XLPE Cup is in line or below with the class, as defined by overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.68% (0.45%-1.02%) vs 0.77% (0.76%-0.78%) of the class.;-At 3rd postoperative year: 1.07% (0.77%-1.48%) vs 1.35% (1.34%-1.37%) of the class.;-At 5th postoperative year: 1.62% (1.22%-2.16%) vs 1.90% (1.88%-1.92%) of the class.;-At 7th postoperative year: 2.18% (1.67%-2.86%) vs 2.49% (2.46%-2.52%) of the class.;-At 10th postoperative year: 2.37% (1.81%-3.11%) vs 3.47% (3.44%-3.50%) of the class.;-At 15th postoperative year: 2.6% (1.92%-3.52%) vs 5.56% (5.51%-5.62%) of the class.;-At 18th postoperative year: 2.6% (1.92%-3.52%) vs 7.07% (6.98%-7.15%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary THA: Osteoarthritis,85,Male,,6/29/2024,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;

Additional Manufacturer Narrative

REPORTING QUARTER: 2 (APRIL 1 ¿ JUNE 30, 2026). SUMMARY OF ADVERSE EVENTS: BASED ON REAL WORLD DATA FROM THE AUSTRALIA ORTHOPEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN THE AUSTRALIA FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN TOTAL HIP REPLACEMENT (THR): 1. PRIMARY TOTAL HIP REPLACEMENT (THR): R3 BIOLOX DELTA CERAMIC LINER: A TOTAL OF SIX THOUSAND NINE HUNDRED AND SIXTY-ONE (6,961) HIPS UNDERWENT PRIMARY THR BETWEEN 15-JAN-2007 AND 16-DEC-2025 IN WHICH A R3 BIOLOX DELTA CERAMIC LINER WAS IMPLANTED. OF THESE, THREE HUNDRED AND FORTY-EIGHT (348) HIPS REQUIRED REVISION DUE TO THE FOLLOWING REASONS: SIXTY-TWO (62) HIPS DUE TO FRACTURE, SIXTY-THREE (63) DUE TO LOOSENING, SIXTY-SEVEN (67) DUE TO INFECTION, SIXTY (60) DUE TO PROSTHESIS DISLOCATION, THREE (3) DUE TO LYSIS, FOURTEEN (14) DUE TO PAIN, TEN (10) DUE TO INSTABILITY, NINE (9) DUE TO LEG LENGTH DISCREPANCY, THIRTEEN (13) DUE TO MALPOSITION, SIX (6) DUE TO IMPLANT BREAKAGE STEM, NINE (9) DUE TO METAL RELATED PATHOLOGY, THREE (3) DUE TO WEAR ACETABULAR INSERT, THREE (3) DUE TO IMPLANT BREAKAGE ACETABULAR INSERT, ONE (1) DUE TO IMPLANT BREAKAGE ACETABULAR, TWO (2) DUE TO INCORRECT SIZING, ELEVEN (11) DUE TO WEAR HEAD, ONE (1) DUE TO TUMOUR, ELEVEN (11) DUE TO OTHER REASONS. OF THE 348 TOTAL REVISION SURGERIES, 332 WERE PREVIOUSLY SUBMITTED TO FDA AND 16 NEW REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. SPECTRON EF COCR STANDARD OFFSET FEMORAL STEM: A TOTAL OF FIVE THOUSAND SEVEN HUNDRED AND ONE (5,701) HIPS UNDERWENT PRIMARY THR BETWEEN 14-SEP-1999 AND 15-DEC-2025 IN WHICH A SPECTRON EF COCR STANDARD OFFSET FEMORAL STEM WAS IMPLANTED. OF THESE, THREE-HUNDRED AND SIXTY-SEVEN (367) HIPS REQUIRED REVISION DUE TO THE FOLLOWING REASONS: EIGHTEEN (18) HIPS DUE TO FRACTURE, ONE HUNDRED SIXTY-SEVEN (167) DUE TO LOOSENING, SIXTY-TWO (62) DUE TO INFECTION, SEVENTY-FOUR (74) DUE TO PROSTHESIS DISLOCATION, TWENTY-EIGHT (28) DUE TO LYSIS, ONE (1) DUE TO PAIN, TWO (2) DUE TO INSTABILITY, ONE (1) DUE TO LEG LENGTH DISCREPANCY, ONE (1) DUE TO MALPOSITION, ELEVEN (11) DUE TO WEAR OF ACETABULAR INSERT, ONE (1) DUE TO HETEROTOPIC BONE, ONE (1) DUE TO OTHER REASONS. OF THE 367 TOTAL REVISION SURGERIES, 360 WERE PREVIOUSLY SUBMITTED TO FDA AND 7 NEW REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. BASED ON THE STRATIFICATION USED BY THE AOANJRR, IT IS NOT POSSIBLE TO CORRELATE THE SPECIFIC REASON FOR EACH REVISION PROCEDURE WITH THE PART NUMBERS INVOLVED IN THESE REVISIONS. ALTOGETHER, A TOTAL QUANTITY OF 23 NEW REVISIONS WAS IDENTIFIED DURING THE CURRENT REPORTING QUARTER BASED ON THE DATA OBTAINED FROM THE AUSTRALIAN ORTHOPAEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR) FOR THE SMITH + NEPHEW DEVICES REFERENCED IN THIS REPORT. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATIONS, THE R3 ACETABULAR SYSTEM AND THE SPECTRON HIP STEM SYSTEM PRESENT A FAVORABLE BENEFIT/RISK ASSESSMENT WHEN USED UNDER THE CONDITIONS AND FOR THE PURPOSES INTENDED BY THE MANUFACTURER AND WITH RESPECT TO THE CONTRAINDICATIONS AND PRECAUTIONS FOR USE AND WARNINGS DESCRIBED IN THE INFORMATION MATERIAL SUPPLIED WITH THE DEVICES. THESE SYSTEMS ARE AT LEAST AS SAFE AND EFFECTIVE AS ALL ITS THERAPEUTIC ALTERNATIVES IN THE TARGETED INDICATION. THE INTENDED PURPOSE AND INFORMATION FOR SAFETY INCLUDED IN THE INFORMATION MATERIALS SUPPLIED BY THE MANUFACTURER ARE ADEQUATE AND SUITABLE FOR THE INTENDED USES AND USERS. AUTOMATED INDUSTRY REPORTS DOCUMENTED BY THE AUSTRALIA ORTHOPEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR) FOR THE SMITH+NEPHEW PROSTHESES REFERENCED ABOVE IN THE CORRESPONDING ANALYZED TOTAL HIP REPLACEMENT (THR) PROCEDURES WERE STUDIED. POST-OPERATIVE OUTCOMES FOR EACH STUDY DEVICE WERE COMPARED AGAINST THOSE OF THE CLASS, DEFINED AS ALL PROSTHESES UTILIZED IN THE CORRESPONDING PROCEDURE TYPE AS RECORDED BY THE AUSTRALIA ORTHOPEDIC ASSOCIATION NATIONAL JOINT REPLACEMENT REGISTRY (AOANJRR). R3 ACETABULAR SYSTEM: CUMULATIVE REVISION RATES DEMONSTRATED NO STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THE REVISION RATES OF THE STUDY DEVICE AND THE THR CLASS FROM THE 1ST THROUGH THE 13TH POSTOPERATIVE YEAR, AS DETERMINED BY OVERLAPPING 95% CONFIDENCE INTERVALS. HOWEVER, FROM THE 14TH POSTOPERATIVE YEAR ONWARD (YEARS 14¿18), THE CONFIDENCE INTERVALS DO NOT OVERLAP, INDICATING A STATISTICALLY SIGNIFICANT DIFFERENCE, WITH THE STUDY DEVICE DEMONSTRATING LOWER CUMULATIVE REVISION RATES COMPARED TO THE THR CLASS. SPECTRON HIP STEM SYSTEM: CUMULATIVE REVISION RATES DETERMINED THAT THE REVISION RATES OF THE STUDY DEVICE ARE STATISTICALLY SIGNIFICANTLY LOWER THAN THE THR CLASS DURING THE EARLY POSTOPERATIVE PERIOD (YEARS 1-8) AND STATISTICALLY SIGNIFICANTLY HIGHER THAN THE THR CLASS FROM YEAR 9 ONWARDS, AS DETERMINED BY NON-OVERLAPPING 95% CONFIDENCE INTERVALS. THE PROPORTION OF HIPS WITH A PRIMARY DIAGNOSIS OF OSTEOARTHRITIS WAS SUBSTANTIALLY LOWER IN THE SPECTRON EF REVISION STEM COHORT (15.3%) COMPARED TO THE CLASS (87.8%), WHILE THE PROPORTIONS OF MORE COMPLEX INDICATIONS, INCLUDING FRACTURED NECK OF FEMUR, FAILED INTERNAL FIXATION, AND TUMOUR, WERE HIGHER IN THE SPECTRON EF REVISION STEM COHORT THAN IN THE CLASS. IN CONSIDERATION OF THE DIFFERENCES IN PATIENT INDICATIONS AND CASE COMPLEXITY BETWEEN THE SPECTRON EF REVISION STEM COHORT AND THE CLASS, THE OBSERVED REVISION RATES ARE CONSIDERED TO BE INFLUENCED, AT LEAST IN PART, BY THE MORE CHALLENGING CLINICAL SCENARIOS IN WHICH THE DEVICE IS USED. THE IDENTIFIED REASONS FOR REVISION ARE CONSISTENT WITH RECOGNIZED COMPLICATIONS OF TOTAL HIP ARTHROPLASTY AND DO NOT IDENTIFY NEW OR UNEXPECTED SAFETY CONCERNS. SPECIFIC ANALYSIS FOR EACH SUBJECT DEVICE IN SCOPE OF THIS MDR SUBMISSION IS PROVIDED IN THE ATTACHED .CSV FILE. BASED ON THE REVIEW OF OTHER CLINICAL SOURCES SUCH AS CLINICAL ACTIVITIES, COMPLAINT DATA, PUBLISHED LITERATURE AND OTHER JOINT REGISTRIES, NO INCREASED RISKS TO HEALTH OR AN INCREASED TREND IN ANY OF THE ADVERSE EVENTS SUMMARIZED ABOVE HAVE BEEN IDENTIFIED. THE REPORTED ADVERSE EVENTS RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. NO INDIVIDUAL INVESTIGATIONS INTO THE REPORTED ADVERSE EVENTS ARE DEEMED NECESSARY. ADDITIONAL ACTION(S) TAKEN: NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED.

Description of Event or Problem

BASED ON REAL WORLD DATA FROM THE NATIONAL JOINT REGISTRY (NJR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN UNITED KINGDOM FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN TOTAL HIP ARTHROPLASTY (THA): 1. PRIMARY TOTAL HIP ARTHROPLASTY (THA): R3 XLPE ACETABULAR LINER: A TOTAL OF SEVENTY-FIVE THOUSAND THREE HUNDRED AND SEVENTY-NINE (75,379) HIPS UNDERWENT PRIMARY THA BETWEEN 13-MAY-2007 AND 26-JAN-2026 IN WHICH A R3 XLPE ACETABULAR LINER WAS IMPLANTED. OF THESE, NINE HUNDRED AND FIFTY (950) HIPS REQUIRED REVISION DUE TO THE FOLLOWING REASONS: TWO HUNDRED THIRTY FOUR (234) HIPS DUE TO INFECTION, TWO HUNDRED EIGHTY FOUR (284) DUE TO DISLOCATION OR SUBLUXATION, ONE HUNDRED SIXTY ONE (161) DUE TO PERIPROSTHETIC FRACTURE OF THE STEM, EIGHTY NINE (89) DUE TO PERIPROSTHETIC FRACTURE, FIFTY SIX (56) DUE TO ASEPTIC LOOSENING OF THE STEM, FORTY EIGHT (48) DUE TO SOCKET MALALIGNMENT, FORTY (40) DUE TO OTHER REASONS, THIRTY ONE (31) DUE TO PAIN, TWENTY THREE (23) DUE TO STEM MALALIGNMENT, TWENTY ONE (21) DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS, TWENTY (20) DUE TO ASEPTIC LOOSENING OF THE SOCKET, FOURTEEN (14) DUE TO WEAR OF THE ACETABULAR COMPONENT, TWELVE (12) DUE TO IMPLANT FRACTURE OF THE STEM, ELEVEN (11) DUE TO PERIPROSTHETIC FRACTURE OF THE SOCKET, TEN (10) DUE TO LYSIS OF THE STEM, EIGHT (8) DUE TO IMPLANT FRACTURE OF A NON-CERAMIC COMPONENT OF THE STEM, EIGHT (8) DUE TO LEG LENGTH DISCREPANCY, SEVEN (7) DUE TO DISSOCIATION OF THE LINER, FIVE (5) DUE TO INCORRECT SIZING OF THE HEAD, FOUR (4) DUE TO LYSIS OF THE SOCKET, TWO (2) DUE TO IMPLANT FRACTURE OF THE HEAD, TWO (2) DUE TO IMPLANT FRACTURE OF A NON-CERAMIC COMPONENT OF THE HEAD, TWO (2) DUE TO INCORRECT SIZING OF THE SOCKET, TWO (2) DUE TO IMPLANT FRACTURE OF A NON-CERAMIC COMPONENT OF THE SOCKET, ONE (1) DUE TO IMPLANT FRACTURE OF THE SOCKET, ONE (1) DUE TO IMPLANT FRACTURE OF A CERAMIC COMPONENT OF THE STEM, AND ONE (1) DUE TO IMPLANT FRACTURE OF A CERAMIC COMPONENT OF THE SOCKET. OF THE 950 TOTAL REVISION SURGERIES, 805 WERE PREVIOUSLY SUBMITTED TO FDA AND 145 NEW REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. REFLECTION XLPE ALL-POLY CUP: A TOTAL OF THREE THOUSAND FOUR HUNDRED FORTY-NINE (3,449) HIPS UNDERWENT PRIMARY THA PROCEDURES BETWEEN 13-SEP-2006 AND 23-MAR-2026, USING A REFLECTION XLPE ALL-POLY CUP. OF THESE, SIXTY (60) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: NINETEEN (19) HIPS DUE TO PERIPROSTHETIC FRACTURE OF THE STEM, FIFTEEN (15) HIPS DUE TO INFECTION, FOURTEEN (14) HIPS DUE TO DISLOCATION/SUBLUXATION, TEN (10) HIPS DUE TO ASEPTIC LOOSENING OF THE SOCKET, FIVE (5) HIPS DUE TO ASEPTIC LOOSENING OF THE STEM, FIVE (5) HIPS DUE TO MALALIGNMENT OF THE SOCKET, THREE (3) HIPS DUE TO WEAR OF THE ACETABULAR COMPONENT, TWO (2) HIPS DUE TO LYSIS OF THE SOCKET, TWO (2) HIPS DUE TO MALALIGNMENT OF THE STEM, TWO (2) HIPS DUE TO OTHER-UNKNOWN REASONS, AND TWO (2) HIPS DUE TO PERIPROSTHETIC FRACTURE OF THE SOCKET, AND ONE (1) HIP DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS, ONE (1) HIP DUE TO IMPLANT FRACTURE OF THE CERAMIC COMPONENT OF THE STEM, ONE (1) HIP DUE TO LYSIS OF THE STEM, AND ONE (1) HIP DUE TO PAIN. OF THE 60 TOTAL REVISION SURGERIES, 56 WERE PREVIOUSLY SUBMITTED TO FDA AND 4 NEW REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. 2. REVISION TOTAL HIP ARTHROPLASTY (THA): R3 XLPE ACETABULAR LINER: A TOTAL OF NINE HUNDRED SIXTY-TWO (962) HIPS UNDERWENT REVISION THA PROCEDURES BETWEEN 10-SEP-2008 AND 20-JAN-2026, USING AN R3 XLPE ACETABULAR LINER. OF THESE, EIGHTY NINE (89) HIPS WERE LATER RE-REVISED DUE TO THE FOLLOWING COMPLICATIONS: TWENTY FOUR (24) HIPS DUE TO DISLOCATION/SUBLUXATION, TWENTY THREE (23) HIPS DUE TO INFECTION, FIFTEEN (15) HIPS DUE TO ASEPTIC LOOSENING OF THE SOCKET, ELEVEN (11) HIPS DUE TO PERIPROSTHETIC FRACTURE OF THE STEM, TEN (10) HIPS DUE TO PAIN, EIGHT (8) HIPS DUE TO ASEPTIC LOOSENING OF THE STEM, SIX (6) HIPS DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS, TWO (2) HIPS DUE TO MALALIGNMENT OF THE SOCKET, TWO (2) HIPS DUE TO OTHER-UNKNOWN REASONS, AND TWO (2) HIPS DUE TO WEAR OF THE ACETABULAR COMPONENT, AND ONE (1) HIP DUE TO LINER DISSOCIATION, ONE (1) HIP DUE TO PERI PROSTHETIC FRACTURE, ONE (1) HIP DUE TO STEM LYSIS, AND ONE (1) HIP DUE TO PERIPROSTHETIC FRACTURE OF THE SOCKET. OF THE 89 TOTAL REVISION SURGERIES, 78 WERE PREVIOUSLY SUBMITTED TO FDA AND 11 NEW REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. REFLECTION ALL-POLY XLPE CUP: A TOTAL OF FIFTY-FOUR (54) HIPS UNDERWENT REVISION THR BETWEEN 23-JAN-2007 AND 10-APR-2026 IN WHICH A REFLECTION ALL-POLY XLPE CUP WAS IMPLANTED. OF THESE, EIGHT (8) HIPS REQUIRED RE-REVISION DUE TO THE FOLLOWING REASONS: THREE (3) HIPS DUE TO INFECTION, TWO (2) DUE TO PAIN, ONE (1) DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS, ONE (1) DUE TO ASEPTIC LOOSENING OF THE SOCKET, ONE (1) DUE TO LYSIS OF THE SOCKET, ONE (1) DUE TO LYSIS OF THE STEM, ONE (1) DUE TO PERIPROSTHETIC FRACTURE OF THE STEM, ONE (1) DUE TO WEAR OF THE ACETABULAR COMPONENT, AND ONE (1) DUE TO OTHER REASONS. OF THE 8 TOTAL REVISION SURGERIES, 6 WERE PREVIOUSLY SUBMITTED TO FDA AND 2 NEW REVISIONS WERE IDENTIFIED DURING THIS REPORTING QUARTER. REFLECTION XLPE ACETABULAR LINER: A TOTAL OF ONE HUNDRED AND NINETY-TWO (192) HIPS UNDERWENT REVISION THA BETWEEN 06-OCT-2004 AND 09-MAR-2015 IN WHICH A REFLECTION XLPE ACETABULAR LINER WAS IMPLANTED. OF THESE, TWENTY-EIGHT (28) HIPS REQUIRED RE-REVISION DUE TO THE FOLLOWING REASONS: EIGHT (8) HIPS DUE TO INFECTION, SIX (6) HIPS DUE TO DISLOCATION/SUBLUXATION, FOUR (4) HIPS DUE TO PAIN, THREE (3) HIPS DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE SOCKET, THREE (3) HIPS DUE TO ASEPTIC LOOSENING ASSOCIATED WITH THE STEM, THREE (3) HIPS DUE TO IMPLANT FRACTURE ASSOCIATED WITH THE FEMORAL STEM, TWO (2) HIPS DUE TO OTHER/UNKNOWN REASONS, ONE (1) HIP DUE TO PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE SOCKET, ONE (1) HIP DUE TO PERIPROSTHETIC FRACTURE ASSOCIATED WITH THE STEM, AND ONE (1) HIP DUE TO AN UNSPECIFIED PERIPROSTHETIC FRACTURE. OF THE 28 TOTAL REVISION SURGERIES, 27 WERE PREVIOUSLY SUBMITTED TO FDA AND 1 NEW REVISION WAS IDENTIFIED DURING THIS REPORTING QUARTER. MULTIPLE REASONS FOR REVISION AND RE-REVISION MAY BE LISTED FOR A SINGLE PROCEDURE. ALTOGETHER, A TOTAL QUANTITY OF 149 REVISIONS AND 14 RE-REVISIONS (163 EVENTS IN TOTAL) WERE IDENTIFIED DURING THE CURRENT REPORTING QUARTER BASED ON THE NATIONAL JOINT REGISTRY (NJR) FOR THE SMITH+NEPHEW DEVICES REFERENCED IN THIS REPORT.