100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL

Additional Manufacturer Narrative

CONCOMITANT MEDICAL PRODUCTS- COCR MODULAR HEAD # ITEM 11-363660 LOT 063470, UNKNOWN STEM. REVIEW OF SCANNING ELECTRON MICROSCOPY DATA AND PHOTOGRAPHIC IMAGES CONFIRMS THE EVENT. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY 5 YEARS POST-IMPLANTATION DUE TO A FRACTURED ACETABULAR LINER. THE SEM ANALYSIS RESULTS REVEALED THAT THE FEMORAL HEAD AND STEM SHOWED IN-VIVO CORROSION. ATTEMPTS TO OBTAIN MORE INFORMATION HAVE BEEN MADE; HOWEVER, NONE IS AVAILABLE.

Additional Manufacturer Narrative

(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IMPLANT DATE- 5 YEARS AGO. (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY 5 YEARS POST-IMPLANTATION DUE TO A FRACTURED ACETABULAR LINER. ATTEMPTS TO OBTAIN MORE INFORMATION HAVE BEEN MADE; HOWEVER, NONE IS AVAILABLE.