E-POLY 36MM +3 HIWALL LNR SZ23

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. CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: 650-1057, ITEM NAME: CER BIOLOXD OPTION HD 36MM, LOT #: 854430; ITEM NUMBER: 650-1964, ITEM NAME: CER OPTION TYPE 1 TPR SLEEVE -6, LOT #: 834070; ITEM NUMBER: UNKNOWN, ITEM NAME: UNKNOWN STEM, LOT #: UNKNOWN; ITEM NUMBER: UNKNOWN, ITEM NAME: UNKNOWN CUP, LOT #: UNKNOWN. 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.

Description of Event or Problem

IT WAS REPORTED PATIENT WAS REVISED DUE TO LINER FRACTURE, PAIN AND STIFFNESS APPROXIMATELY 6 YEARS POST-IMPLANTATION. THE FRACTURED LINER CAUSED THE HEAD TO RUB ON THE SHELL RESULTING IN DEBRIS IN THE SURROUNDING TISSUES. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

Description of Event or Problem

NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: H2; H3; H6. LEGAL DOCUMENT WAS PROVIDED WITH THE BELOW FINDINGS: SPONTANEOUS ONSET OF PAIN WHILE WALKING AND NOISE FROM LEFT HIP WITH MOVEMENT DIAGNOSTIC STUDIES INDICATE FAILURE OF LINER 'THE POLY INSERT HAD FRAGMENTED INTO MULTIPLE PIECES, THE LINER HAD DISSOCIATED FROM THE ACETABULAR COMPONENT, THERE WAS A SUPERIOR AREA OF HEMISPHERICAL WEAR IN THE METAL FROM GRINDING OF THE CERAMIC HEAD, THE RING-LOC MECHANISM HAD A COLD-WELDED ON ONE OF ITS FREE ENDS' MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: (SUMMARIZED BY HCP) MMI: IMPRESSIONS: LEFT TOTAL HIP ARTHROPLASTY WITH VERTICAL ORIENTATION OF THE ACETABULAR CUP AND POSSIBLE POLYETHYLENE WEAR. ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION. 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.

Description of Event or Problem

NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2021 - 02395.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: (SUMMARIZED BY HCP) SEVERAL PAGES OF OP NOTES AND OFFICE NOTES WERE REVIEWED AND CONFIRMED THE REPORTED EVENTS ACETABULAR WEAR, FRACTURED LINER, SQUEAKING SOUND, AMBULATION, PAIN, NOISE ALONG WITH OTHERS. THE ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION.

Description of Event or Problem

NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

Description of Event or Problem

NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY RETURN OF THE DEVICE. VISUAL INSPECTION CONFIRMED A PORTION OF THE RIM IS FRACTURED FROM THE LINER. THE FRACTURE TRAVELS AROUND THE LINER THROUGH THE LOCKING RING GROOVE. DEBRIS WAS OBSERVED WITHIN THE CRACKS OF THE FRACTURE AND EMBEDDED INTO FRACTURED PORTION. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO RELATED DEVIATIONS/ ANOMALIES WERE IDENTIFIED THAT AFFECT THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION 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

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-02395, 0001825034-2018-09879.

Description of Event or Problem

IT WAS REPORTED PATIENT WAS REVISED DUE TO LINER FRACTURE, PAIN, NOISE AND STIFFNESS APPROXIMATELY 6 YEARS POST-IMPLANTATION. DURING REVISION IT WAS NOTED THAT THE POLY WAS FRACTURED, THE SHELL WAS COLD-WELDED AND THE CERAMIC HEAD WAS WEARING ON THE SHELL. THE POLY, LINER, AND HEAD WERE EXCHANGED. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.