UNKNOWN DVR PLATE

Additional Manufacturer Narrative

REPORTED EVENT WAS CONFIRMED BY REVIEW OF THE PICTURE AND RADIOGRAPHS. A REVIEW OF THE PROVIDED PICTURE NOTED THE PLATE PIERCED THROUGH THE SKIN. REVIEW OF AVAILABLE X-RAYS NOTED THAT THE SIZE OF THE IMPLANT IS APPROPRIATE. THE IMPLANT APPEARS TO HAVE PARTIALLY DISLOCATED RADIALLY WITH A PORTION OF THE HARDWARE IN THE SOFT TISSUES. NO OBVIOUS CONTRIBUTIVE FACTORS ARE SEEN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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

NO ADDITIONAL EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

(B)(4). FOREIGN- (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE WRIST IMPLANT DISLOCATED APPROXIMATELY FOUR YEARS POST INITIAL IMPLANTATION. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.