ACCUFILL BSM 3CC (CE)

Additional Manufacturer Narrative

(B)(4). D11: ITEM# 307.032; LOT# UNK. ITEM# 331.100; LOT# UNK. G2: FOREIGN - EVENT OCCURRED IN SWEDEN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS USED/INJECTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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 THAT THE PATIENT RECEIVED A SCP INJECTION AFTER EXPERIENCING A TRAUMA. APPROXIMATELY THREE (3) MONTHS POST-INJECTION, THE PATIENT CAME IN FOR A FOLLOW UP VISIT WITH JOINT STIFFNESS, IMPACTED GAIT, AND PAIN ALSO BEING MINIMALLY IMPROVED SINCE INJECTION. PATIENT WAS LATER SEEN AGAIN APPROXIMATELY THREE (3) MONTHS LATER PRESENTING BONE EROSION NEAR THE TRAUMA SITE AND INJECTION SITE WITH SOME SWELLING AND REDUCED PAIN. 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. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: LEFT TIBIAL MEDIAL MALLEOLUS CHONDROPLASTY AS NOTED WITH SUBSEQUENT RESORPTION AND PERIOSTEAL REACTION. THE ISSUE OF BONE RESORPTION IS CONFIRMED. WHEN COMPARING THE 1 MONTH POST INJECTION AND THE 6 MONTH POST INJECTION IMAGES, THERE IS CLEAR RESORPTION AT THE CHONDROPLASTY SITE. LOT IDENTIFICATION IS NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, LOT IDENTIFICATION WAS NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT FOR BONE RESORPTION HAS BEEN CONFIRMED THROUGH RADIOGRAPHS. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT 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

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IF ANY FURTHER INFORMATION WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT 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.