PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

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-2026-00323726-1-L1,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L2,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L3,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L4,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L5,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L6,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L7,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L8,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L9,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L10,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L11,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L12,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L13,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L14,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L15,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L16,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L17,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L18,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L19,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L20,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L21,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L22,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L23,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L24,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L25,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L26,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L27,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L28,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L29,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L30,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L31,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L32,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L33,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L34,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L35,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L36,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L37,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L38,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L39,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L40,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L41,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L42,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L43,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L44,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L45,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L46,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L47,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L48,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L49,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L50,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L51,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L52,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L53,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L54,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L55,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L56,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L57,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L58,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L59,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L60,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L61,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L62,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L63,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L64,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L65,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L66,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L67,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L68,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L69,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L70,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L71,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L72,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L73,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From 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 Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L74,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to pain.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L75,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to pain.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L76,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to pain.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L77,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to pain.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L78,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to pain.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L79,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to pain.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L80,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to pain.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L81,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to pain.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L82,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to pain.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L83,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to pain.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L84,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to pain.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L85,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to pain.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L86,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to pain.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L87,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L88,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L89,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L90,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L91,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L92,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L93,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L94,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L95,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L96,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L97,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L98,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L99,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L100,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L101,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L102,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L103,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L104,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L105,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L106,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L107,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L108,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L109,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L110,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L111,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L112,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L113,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L114,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L115,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L116,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L117,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L118,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L119,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L120,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L121,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L122,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L123,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L124,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L125,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L126,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L127,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L128,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L129,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L130,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L131,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L132,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L133,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L134,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L135,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L136,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L137,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L138,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L139,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L140,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L141,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L142,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L143,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L144,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L145,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L146,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L147,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L148,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L149,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L150,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L151,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L152,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L153,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L154,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L155,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L156,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L157,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L158,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L159,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L160,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L161,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to recurrent dislocations.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E1614,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L162,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L163,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L164,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L165,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L166,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L167,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L168,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L169,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L170,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L171,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L172,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L173,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L174,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L175,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L176,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L177,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L178,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L179,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L180,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L181,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L182,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L183,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L184,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L185,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L186,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L187,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L188,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L189,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L190,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L191,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L192,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L193,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L194,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L195,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L196,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L197,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L198,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L199,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L200,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L201,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L202,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L203,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L204,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L205,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L206,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L207,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L208,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L209,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L210,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L211,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L212,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L213,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L214,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L215,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L216,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to aseptic loosening.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L217,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L218,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L219,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L220,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L221,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L222,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L223,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L224,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L225,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L226,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L227,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L228,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L229,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L230,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L231,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L232,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L233,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L234,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L235,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L236,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L237,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L238,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L239,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L240,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L241,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L242,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L243,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L244,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L245,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L246,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00323726-1-L247,,7/17/2026,4/1/2026,R3 Acetabular System ,R3 Acetabular Component,,,,,,,,IN,"It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, one (1) hip was later revised due to other/unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the Norwegian Arthroplasty Register (NAR) from Norway, a total of nine thousand forty seven (9,047) hips underwent primary THA procedures between 01-Jan-2010 and 28-Feb-2026, using R3 Acetabular Components. From these, two hundred forty seven (247) hips were later revised due to the following reasons: seventy three (73) hips due to infection, thirteen (13) hips due to pain, seventy five (75) hips due to recurrent dislocations, twenty nine (29) hips due to periprosthetic fracture, twenty six (26) hips due to aseptic loosening, thirty one (31) hips due to other/unknown reasons. 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 01-Jan-2010 and 28-Feb-2026 in Norway;;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 thousand forty seven (9,047) hips underwent primary THA procedure in which a R3 Acetabular Component was implanted in Norway between 01-Jan-2010 and 28-Feb-2026. ;;The R3 Acetabular components are performing in line with the respective class subcategory at the available follow-up time (10 years).;;The following cumulative revision rates with 95% confidence intervals are presented in this report:;-At 10th postoperative year: 4.0% (3.4%¿4.6%) vs 4.1% 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.",,,,,,,E2401,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 NORWEGIAN ARTHROPLASTY REGISTER (NAR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN NORWAY FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN TOTAL HIP PROCEDURES: 1. PRIMARY TOTAL HIP PROCEDURES - R3 ACETABULAR COMPONENTS: IMPLANTED IN A TOTAL OF NINE THOUSAND FORTY-SEVEN (9,047) HIPS BETWEEN 01-JAN-2010 AND 28-FEB-2026. FROM THESE, TWO HUNDRED FORTY-SEVEN (247) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: SEVENTY THREE (73) HIPS DUE TO INFECTION, THIRTEEN (13) HIPS DUE TO PAIN, SEVENTY FIVE (75) HIPS DUE TO RECURRENT DISLOCATIONS, TWENTY NINE (29) HIPS DUE TO PERIPROSTHETIC FRACTURE, TWENTY SIX (26) HIPS DUE TO ASEPTIC LOOSENING, THIRTY ONE (31) HIPS DUE TO OTHER/UNKNOWN REASONS. IT SHOULD BE NOTED THAT MORE THAN ONE REASON FOR REVISION MAY BE LISTED FOR EACH REVISION SURGERY. 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 THOUSAND FORTY SEVEN (9,047) HIPS UNDERWENT PRIMARY THA PROCEDURE IN WHICH A R3 ACETABULAR COMPONENT WAS IMPLANTED IN NORWAY BETWEEN 01-JAN-2010 AND 28-FEB-2026. THE R3 ACETABULAR COMPONENTS ARE PERFORMING IN LINE WITH THE RESPECTIVE CLASS SUBCATEGORY AT THE AVAILABLE FOLLOW-UP TIME (10 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.

Description of Event or Problem

BASED ON REAL WORLD DATA FROM THE NORWEGIAN ARTHROPLASTY REGISTER (NAR), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN NORWAY FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN TOTAL HIP PROCEDURES: 1. PRIMARY TOTAL HIP PROCEDURES - R3 ACETABULAR COMPONENTS: IMPLANTED IN A TOTAL OF NINE THOUSAND FORTY-SEVEN (9,047) HIPS BETWEEN 01-JAN-2010 AND 28-FEB-2026. FROM THESE, TWO HUNDRED FORTY-SEVEN (247) HIPS WERE LATER REVISED DUE TO THE FOLLOWING REASONS: SEVENTY THREE (73) HIPS DUE TO INFECTION, THIRTEEN (13) HIPS DUE TO PAIN, SEVENTY FIVE (75) HIPS DUE TO RECURRENT DISLOCATIONS, TWENTY NINE (29) HIPS DUE TO PERIPROSTHETIC FRACTURE, TWENTY SIX (26) HIPS DUE TO ASEPTIC LOOSENING, THIRTY ONE (31) HIPS DUE TO OTHER/UNKNOWN REASONS. IT SHOULD BE NOTED THAT MORE THAN ONE REASON FOR REVISION MAY BE LISTED FOR EACH REVISION SURGERY.