PATELLO-FEMORAL TROCHLEA COMPONENT SIZE 5, LEFT

Additional Manufacturer Narrative

(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO BEING IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 THE PROSTHESIS PLASTIC BAG WAS PARTIALLY STUCK ON THE IMPLANT.

Description of Event or Problem

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

Additional Manufacturer Narrative

REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE LIKELY CONDITION OF THE PART WHEN IT LEFT ZIMMER BIOMET CONTROL IS CONSIDERED NON-CONFORMING BASED ON THE PREVIOUS COMPLAINTS FOR THIS ISSUE FOR THIS PART/LOT COMBINATION. THIS DEVICE WAS PACKAGED IN THE POLY BAG WAS RECALLED AS PART OF CAPA THAT WAS COMPLETED IN MARCH 2014. A DESIGN DEFICIENCY OF THE BAG WAS CONSIDERED AS THE ROOT CAUSE OF LDPE BAG ADHESION ONTO HIGHLY POLISHED METAL IMPLANTS AT THE TIME THE CAPA WAS IMPLEMENTED. THE REPORTED ISSUE IS ATTRIBUTED TO SEVERAL FACTORS INCLUDING INVENTORY ADJUSTMENT, PRODUCT RELOCATION, PRODUCT CONSIGNMENT, AND LOT (BATCH) NUMBER CHANGES, WHICH LED TO THE PRODUCT ESCAPING THE RECALL IN PLACE. THE ROOT CAUSE OF THE STICKY BAG ISSUE IS A DESIGN DEFICIENCY. 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.