22.2MM DIA COCR MOD HD STD NK

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

Additional Manufacturer Narrative

(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. LEGAL NOTIFICATION.

Description of Event or Problem

IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 3.5 YEARS POST IMPLANTATION DUE TO DISASSOCIATION OF THE FEMORAL HEAD FROM A COMPETITOR POLY FEMORAL HEAD, AS WELL AS DISLOCATION OF COMPETITOR DEVICES. DURING THE PREVIOUS SURGERY, THE SURGEON CEMENTED COMPETITOR CUP INTO BIOMET CUP WITH COMPETITOR METAL LINER AND COMPETITOR DUAL MOBILITY POLY HEAD. OP NOTES INDICATE THE BACK OF THE PROSTHESIS HAD GONE THROUGH THE FASCIA. THERE WAS NO SOFT TISSUE ATTACHMENT TO THE GREATER TROCHANTER POSTERIORLY, SUPERIORLY, AND VERY SPARSELY ANTERIORLY; ABDUCTOR DEFICIENT; ESSENTIALLY NAKED CAPSULE.

Additional Manufacturer Narrative

THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE DEVICES WERE USED OFF-LABEL. IT IS UNKNOWN WHETHER THIS INCOMPATIBLE USAGE CONTRIBUTED TO THE REPORTED EVENT.

Description of Event or Problem

IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 3.5 YEARS POST IMPLANTATION DUE TO DISASSOCIATION OF THE FEMORAL HEAD FROM A COMPETITOR POLY BEARING, AS WELL AS DISLOCATION OF COMPETITOR DEVICES. DURING THE PREVIOUS SURGERY, THE SURGEON CEMENTED COMPETITOR CUP INTO BIOMET CUP WITH COMPETITOR METAL LINER AND COMPETITOR DUAL MOBILITY POLY HEAD. OP NOTES INDICATE THE BACK OF THE PROSTHESIS HAD GONE THROUGH THE FASCIA. THERE WAS NO SOFT TISSUE ATTACHMENT TO THE GREATER TROCHANTER POSTERIORLY, SUPERIORLY, AND VERY SPARSELY ANTERIORLY; ABDUCTOR DEFICIENT; ESSENTIALLY NAKED CAPSULE.