E-POLY 36MM +3 HIWALL LNR SZ23

Additional Manufacturer Narrative

(B)(4).M, D10: CAT #: 12-104152 / M/H RADIAL 3-HOLE SHELL 52MM/ LOT #: 617790 CAT #: 11-363660 / 36MM COCR MOD HD -6MM / LOT #: 710310 G2: JAPAN THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY THIRTEEN YEARS POST IMPLANTATION DUE TO INSTABILITY AND PAIN. DURING THE PROCEDURE, THE SURGEON NOTED WEAR TO THE LINER AND MALALIGNMENT OF THE CUP. THE CUP WAS REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4;D4;G3;H2;H3;H4;H6;H10 NO PRODUCT WAS RETURNED; HOWEVER, PICTURES WERE PROVIDED. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE SHELL SHOWED SIGNS OF WEAR. THE RING STILL APPEARED ASSEMBLED WITHIN THE GROOVE, AND THE LINER HAS TWO HOLES TYPICALLY FROM REMOVING IT FROM THE SHELL. NO HEAD WAS RETURNED (REMAINS IMPLANTED). A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE REPORTED PRODUCTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE EVENT CANNOT BE CONFIRMED. 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 IS AVAILABLE AT THE TIME OF THIS REPORT.