2G OTOMIMIX

Description of Event or Problem

IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING BONE CEMENT, THE PRIMARY PACKAGING WAS FOUND TO BE DEFECTIVE, AS THE CEMENT LEAKED INTO THE SECONDARY PACKAGING, RENDERING IT UNUSABLE. THE EVENT WAS IDENTIFIED PRIOR TO USE, AND THE AFFECTED UNIT WAS SEQUESTERED. ANOTHER CEMENT UNIT WAS PROVIDED TO COMPLETE THE PROCEDURE. NO CLINICAL CONSEQUENCES WERE REPORTED FOR THE PATIENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

Additional Manufacturer Narrative

(B)(4). FOREIGN - THE EVENT OCCURRED IN FRANCE. THE CUSTOMER HAS NOT INDICATED WHETHER THE PRODUCT WILL BE ZIMMER BIOMET FOR INVESTIGATION, AND THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND THAT 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

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4, B5, D4, G3, G6, H2, H3, H4, H6, H11 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. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS UNCONFIRMED. 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 IS AVAILABLE AT THE TIME OF THIS REPORT.