ZIMMER BIOMET COMPLAINT (B)(4). LOT NUMBER - POSSIBLE LOT NUMBERS ARE: 016570, 582090, 402320. EXPIRATION DATE - LOT 016570: JUNE 2, 2020; LOT 582090: MAY 2, 2020; LOT 402320: NOVEMBER 1, 2019. HEALTH PROFESSIONAL - INITIAL REPORTER HAS AN EMAIL ASSOCIATED WITH A HOSPITAL. OCCUPATION - INITIAL REPORTER HAS AN EMAIL ASSOCIATED WITH A HOSPITAL, NO OTHER INFORMATION. INITIAL REPORTER ALSO SENT REPORT TO FDA - THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. REPORT SOURCE - (B)(6). DEVICE MANUFACTURE DATE - LOT 016570: JUNE 2, 2018; LOT 582090: MAY 2, 2018; LOT 402320: NOVEMBER 1, 2017. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
D
Patient 1
IT WAS REPORTED THAT THE CUSTOMER HAS EXPERIENCED AN ISSUE DURING SURGERY WHERE THE PRODUCT HAS BEEN TOO LOOSE OR TOO DRY, BUT STILL NOT HARDENED AFTER 10 MINUTES. THE EXACT DURATION OF THE SURGICAL DELAY WAS NOT PROVIDED, BUT IT WAS REPORTED THAT THERE WAS A DELAY IN SURGERY EXCEEDING 30 MINUTES. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.