2G OTOMIMIX

Additional Manufacturer Narrative

ZIMMER BIOMET COMPLAINT (B)(4). D10 ¿ MEDICAL PRODUCTS . ITEM # 7014-3266, LOT # 091260; 2G OTOMIMIX. G3: FOREIGN SOURCE: FRANCE. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001032347-2024-00063.

Description of Event or Problem

IT IS REPORTED THAT DURING THE PREPARATION OF THE OTOMIMIX DURING A TYMPANOPLASTY, IT WAS NOTICED THAT THE CEMENT DID NOT HAVE THE RIGHT CONSISTENCY. IT IS IMPOSSIBLE TO USE CEMENT BECAUSE IT IS TOO LIQUID LIKE. A SECOND BATCH OF CEMENT WAS PREPARED AND THAT ONE HAD THE SAME MALFUNCTION. IT WAS TOO LIQUID LIKE AND ONCE IT DRIED, IT CRUMBLED. AS A RESULT, THE PATIENT WAS UNABLE TO UNDERGO OSSICULOPLASTY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS UNCONFIRMED. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THIS REPORT IS BEING SUBMITTED TO UPDATE ADDITIONAL INFORMATION IN SECTIONS B4, B5, G3, G6, H2, H3, H4, H6, AND H11.

Description of Event or Problem

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