VNGD SSK PSC INTLK FMRL 60 LT

Description of Event or Problem

IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE TWELVE YEARS POST IMPLANTATION DUE TO FRACTURED FEMORAL PROSTHESIS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

Additional Manufacturer Narrative

(B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: SERIES A PAT STD 31 3 PEG CATALOG # 184764 LOT # 903730. BIOMET ILOK STEM TIB TRAY 67MM CATALOG # 141512 LOT # 335530. BMT SPLINED KNEE STM 16X80 CATALOG # 141616 LOT # 665450. VNGD SSKPSC TIB BRG S 14X63/67 CATALOG # 183824 LOT # 797410. BMT SPLINED KNEE STM 14X80 CATALOG # 141614 LOT # 345850. REFOBACIN REVISION 1X40G CATALOG # 3011630001 LOT # 911BAE2503. REFOBACIN REVISION 1X40G CATALOG # 3011630001 LOT # 926AAF2204. REPORT SOURCE: (B)(6). 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.

Additional Manufacturer Narrative

VISUAL EXAMINATION OF THE PROVIDED PHOTO FOUND THE FEMORAL COMPONENT FRACTURED. THE DEVICE WAS NOT RETURNED FOR FURTHER EVALUATION. MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIATIONS / ANOMALIES IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT 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

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