PROFEMUR® VVS SHORT 127° MODULAR NECK

Additional Manufacturer Narrative

THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

Description of Event or Problem

ALLEGEDLY, A STUDY FROM ULGELMO ET AL. 2022 (LATE INTRAPROSTHETIC DISLOCATION OF A MONOBLOCK DUAL-MOBILITY CUP CEMENTED INTO A WELL-FIXED CEMENTLESS ACETABULAR SHELL. A CASE REPORT) WAS REVIEWED AND INFORMATION IS PROVIDED BELOW: FIVE YEARS AFTER THE FIRST REVISION, THE PATIENT EXPERIENCED THREE EPISODES OF ANTERIOR DISLOCATION WITHIN FIVE MONTHS, PROMPTING A SECOND REVISION SURGERY. A DUAL MOBILITY (DM) CUP WAS CEMENTED INTO THE RETAINED SHELL USING THE "DOUBLE-SOCKET" TECHNIQUE. RETAINED MPO PRODUCTS: UNKNOWN FEMORAL STEM DYNASTY® SHELL.

Additional Manufacturer Narrative

THE ALLEGED COMPLAINT COULD NOT BE CONFIRMED. REVIEW OF THE COMPLAINT, (B)(4) LOT UNK AND PHA012XX LOT UNK, DOES NOT REVEAL ANY EVIDENCE OF FAILURE INVOLVING THESE IMPLANTS. MPO WAS MADE AWARE OF THIS ALLEGED FAILURE THROUGH A STUDY FROM ULGELMO ET AL. 2022. THESE IMPLANTS WERE NOT RETURNED FOR INVESTIGATION, NOR WERE ANY PICTURES OR ADDITIONAL MEDICAL DOCUMENTATION PROVIDED TO ASSIST WITH THE INVESTIGATION. IT IS UNKNOWN WHEN THESE IMPLANTS WERE MANUFACTURED, OR IF THEY WERE MANUFACTURED TO SPECIFICATION DUE TO THE UNKNOWN LOT NUMBERS. THERE ARE NO TRENDS FOR THESE PRODUCT FAMILIES AND FAILURE. THE MPO HIP SYSTEMS PACKAGE INSERT (150803-9) LISTS? DISLOCATION, MIGRATION AND/OR SUBLUXATION OF PROSTHETIC COMPONENTS FROM IMPROPER POSITIONING, TRAUMA, LOSS OF FIXATION AND/OR MUSCLE AND FIBROUS TISSUE LAXITY? AS A POTENTIAL ADVERSE EFFECT OF TOTAL HIP ARTHROPLASTY IMPLANTS. ADDITIONALLY, IT ALSO STATES? PERIODIC, LONG-TERM FOLLOW-UP IS RECOMMENDED TO MONITOR THE POSITION AND STATE OF THE PROSTHETIC COMPONENTS, AS WELL AS THE CONDITION OF THE ADJOINING BONE. PERIODIC POST-OPERATIVE X-RAYS ARE RECOMMENDED FOR CLOSE COMPARISON WITH EARLY POST-OP CONDITIONS TO DETECT LONG TERM EVIDENCE OF CHANGES IN POSITION, LOOSENING, BENDING, OR CRACKING OF COMPONENTS? HOWEVER, IT CANNOT BE CONCLUDED WHAT THE LEVEL OF CONTRIBUTION, IF ANY, THAT THE PRODUCT HAD TO THE COMPLAINT. NO FURTHER EVALUATIONS CAN BE MADE WITHOUT RETURN OF THE PRODUCT OR RECEIPT OF OTHER CLINICAL INFORMATION. METHODS: DEVICE NOT RETURNED (4114). TREND ANALYSIS (4110). RESULTS: NO FINDINGS AVAILABLE (3221). CONCLUSIONS: DEVICE CONDITION IS UNKNOWN. DEVICE WAS USED FOR TREATMENT. CAUSE NOT ESTABLISHED (4315). KNOWN INHERENT RISK OF DEVICE (22). CORRECT TYPE OF REPORTABLE EVENT: SERIOUS INJURY.