E-POLY 36MM +3 MAXROM LNR SZ23

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. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED DEVICES IDENTIFIED THAT THE LOCK RING WAS REMOVED AND BENT. THE HEAD SHOWED SCUFFING, AND THE LINER WAS FRACTURED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

Additional Manufacturer Narrative

(B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM #11-363662 COCR MOD HD STD LOT #915940, ITEM #11-106052 R/B RLOC LHOLE SHL LOT #805900, ITEM # 51-104140 TPRLC 133 T1 PPS LOT #3391418. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-02493, 0001825034-2019-02494.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT HIP PROCEDURE. SUBSEQUENTLY, APPROXIMATELY FOUR MONTHS POST OP THE PATIENT WAS REVISED DUE TO METALLOSIS AND POLY LINER FRACTURE. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER, NONE WAS AVAILABLE.