ARCOS CON SZ A STD 50MM

Description of Event or Problem

IT WAS REPORTED A PATIENT UNDERWENT HIP REVISION SURGERY APPROXIMATELY 2.5 YEARS POST IMPLANTATION DUE TO INFECTION, PERIPROSTHETIC FRACTURE, MALUNION AND LOOSENING. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES MMI: IMPRESSIONS: MODERATE-SIZED PERIPROSTHETIC ZONE OF LUCENCY IN THE RIGHT FEMORAL COMPONENT LOCATED AT THE TROCHANTERIC AND SUBTROCHANTERIC REGION SUGGESTS LOOSENING AND/OR INFECTION. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. CONCOMITANT MEDICAL PRODUCTS: CATALOG#: 11-300812 ARCOS 12X150MM SPL TPR DIST LOT#: 303240. (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-02539.