UNK MANDIBLE COMPONENT

Additional Manufacturer Narrative

(B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2021-00076, 0001032347-2021-00078, 0001032347-2021-00079. ITEM# 24-6563; LOT# 975190C ITEM# UNK FOSSA SCREW; LOT# UNK ITEM# UNK MANDIBLE SCREW; LOT# UNK CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS 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 PATIENT RECEIVED A JOINT PROSTHESIS APPROXIMATELY EIGHT (8) MONTHS AGO. SUBSEQUENTLY, PATIENT IS EXPERIENCING UNKNOWN SYMPTOMS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

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. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4; B5; G3; G6; H1; H2 UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. IT WAS CLARIFIED THAT THERE ARE NO KNOWN COMPLAINTS WITH THE LEFT-SIDE IMPLANTS. IT WAS CONFIRMED THE PT DOES NOT HAVE RIGHT-SIDE IMPLANTS AT THIS TIME, BUT THE OFFICE WAS WANTING TO DO IMAGING ON THAT SIDE AND NEED PART INFO AND IFU INFORMATION. THE INITIAL REPORT SHOULD BE VOIDED. 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.