E-POLY 36MM +3 MAXROM LNR SZ23

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE LINER TO BE FRACTURED AS REPORTED. NO OTHER INFORMATION COULD BE OBTAINED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED FINDINGS OF THE REPORTED ISSUES. IMPRESSIONS: RIGHT THA WITH ASYMMETRIC POSITION OF THE FEMORAL HEAD WITHIN THE ACETABULAR CUP SUGGESTING POLYETHYLENE WEAR OF THE ACETABULAR COMPONENT. A DEFINITIVE ROOT CAUSE CANNOT 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.

Description of Event or Problem

THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 12 AND A HALF YEARS POST IMPLANTATION DUE TO THE LINER HAVING WORN THROUGH AND CRACKED IN SITU. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative

(B)(4), D10: ASSOCIATED ITEM NUMBER 650-0660, ITEM NAME DELTA CERAMIC FEM HD 36/- 3MM, LOT # 2180918. G2: FOREIGN: AUSTRALIA, THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT¿S LOCATION IS NOT KNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED H3 OTHER TEXT : DEVICE WAS DISCARDED.