GENDER SOLUTIONS PATELLO-FEMORAL TROCHLEA COMPONENT SIZE 3 RIGHT

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE PRODUCTS WERE EVALUATED THROUGH MANUFACTURING REVIEW, HOWEVER, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE IDENTIFIED. PER THE GENDER SOLUTIONS PFJ PACKAGE INSERT, PAIN AND MALALIGNMENT ARE KNOWN POTENTIAL ADVERSE EFFECTS OF THIS PROCEDURE. A DEFINITIVE ROOT CAUSE COULD NOT 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.

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. CONCOMITANT PRODUCTS- CONCOMITANT DEVICES - NEXGEN ALL POLY PATELLA SIZE 29MM CATALOG #: 00597206529 LOT #: 62413061. MULTIPLE MDR REPORTS WERE FILED FOR THIS PATIENT, PLEASE SEE ALL REPORTS ASSOCIATED WITH THIS EVENT: 0001822565-2017-08332; 0002648920-2018-00768.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN, A BURNING SENSATION AND IMPROPER SEATING OF THE PROSTHESES APPROXIMATELY FOUR YEARS POST-OPERATIVELY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

Additional Manufacturer Narrative

(B)(4). PRODUCT IS NOT RETURNED TO ZIMMER BIOMET. 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 PATIENT UNDERWENT RIGHT PARTIAL PATELLA FEMORAL PROCEDURE AND WAS REVISED DUE TO PAIN AND BURNING SENSATION. ALSO THE IMPLANT NOT SEATED PROPERLY.