UNK CONDYLE
Received Feb 11, 2021
Report 0001032347-2021-00065 · MDR key 11313537
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
Not reported
- No Information
- No Information
Narrative
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. UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE DEVICE THAT THE PATIENT PREVIOUSLY HAD IMPLANTED WAS NOT A ZIMMER BIOMET DEVICE; THEREFORE, ZIMMER BIOMET DOES NOT HOLD RESPONSIBILITY TO REPORT THIS EVENT. 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.
Additional Manufacturer Narrative
(B)(4). CONCOMITANT MEDICAL PRODUCTS: DEVICE REQUESTED FOR REVISION - ITEM# TMJPM-3224 ; LOT# UNK. REPORT SOURCE: FOREIGN - (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. 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 APPROXIMATELY THREE (3) WEEKS AGO, THAT THE PATIENT UNDERWENT A RIGHT TMJ PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING INDICATED FOR A REVISION TO REPLACE THE CONDYLE DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.