OTOMIMIX CALCIUM PHOSHPATE

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; H3; H6; H11. SUPPLIED PHOTOS OF PRODUCT WERE REVIEWED AND IT CAN BE SEEN THAT THE LIQUID LABEL IS DISCOLORED AND AS WELL LIQUID BOTTLE APPEARS TO NOT HAVE LIQUID WITHIN IT. AS WELL, THERE IS A LABEL VERIFYING LOT AND ITEM TO REPORTED ITEM/LOT. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED A DEVICE DESIGN ISSUE. A CORRECTIVE ACTION WAS PREVIOUSLY INITIATED TO ADDRESS THIS ISSUE. 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

ZIMMER BIOMET COMPLAINT (B)(4). G2: FOREIGN - UNITED KINGDOM. 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.

Description of Event or Problem

IT WAS REPORTED THAT THE BOTTLE WAS EMPTY UPON RECEIPT. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.