REFOBACIN BONE CMNT R 1X40 JP

Additional Manufacturer Narrative

(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H6, H11. THE PRODUCT INVOLVED IN THE REPORTED EVENT WAS NOT RETURNED FOR INVESTIGATION; HOWEVER, PICTURES WERE PROVIDED AND SHOWS THE INNER CEMENT POUCH IN A PLASTIC BAG. THE INNER CEMENT POUCH SEEMS EMPTY. BASED ON THE PICTURES IT IS NOT POSSIBLE TO SEE THE BLACK FOREIGN SUBSTANCE. INDEED, IT IS UNCLEAR IF THE BLACK POINT INSIDE THE CIRCLE IS A FOREIGN SUBSTANCE OR A MARKER MARK. THE PRODUCT IDENTIFICATION IS CONFIRMED WITH THE STICKER ON THE PACKAGING. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. A REVIEW OF THE RAW MATERIAL CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND 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 IS AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, D9, G3, G6, H2, H3, H6, H11. VISUAL EXAMINATION OF THE RETURNED PRODUCT SHOWS THAT THE INNER CEMENT POUCH IS EMPTY. SOME SCOTCH TAPE HAS BEEN APPLIED IN THE AREA WHERE TRACES OF POWDER CAN BE SEEN. NO DEBRIS IS VISIBLE. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. A REVIEW OF THE RAW MATERIAL CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATION. COMPLAINTS ARE MONITORED PER COMPLAINT TRENDING PROCESS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND 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 IS AVAILABLE AT THE TIME OF THIS REPORT.

Description of Event or Problem

IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, A FOREIGN SUBSTANCE WAS FOUND IN THE BONE CEMENT POLYMER POWDER. AN ALTERNATIVE CEMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED HARM, HEALTH IMPACTS, OR SURGICAL COMPLICATIONS TO THE PATIENT DUE TO THIS INCIDENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; NO FURTHER ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

(B)(4). D4 - THIS PRODUCT IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). G2 - FOREIGN: JAPAN. G4 - THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K171540. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.