Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Additional Manufacturer Narrative

(B)(4). THE CUSTOMER INDICATED THAT THE PRODUCT REMAINS IMPLANTED; THEREFORE, IT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A HIP REVISION APPROXIMATELY 31 YEARS POST IMPLANTATION, DUE TO WEAR OF THE ACETABULAR CUP COMPONENT. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.