E-POLY 36MM +3 MAXROM LNR SZ23

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

Description of Event or Problem

IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION PROCEDURE APPROXIMATELY ELEVEN (11) MONTHS POST-IMPLANTATION DUE TO A FRACTURED ACETABULAR LINER. DURING THE PROCEDURE, THE ACETABULAR CUP, LINER AND FEMORAL HEAD WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCTS.

Additional Manufacturer Narrative

THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH SINCE THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND, IF WARRANTED, FURTHER MEDWATCH REPORTS WILL BE SUBMITTED. PRODUCT NOT RETURNED.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(6) 2016 DUE TO A FRACTURED ACETABULAR LINER. DURING THE PROCEDURE, THE ACETABULAR CUP, ACETABULAR LINER AND FEMORAL HEAD WERE REMOVED AND REPLACED WITH COMPETITOR COMPONENTS.