UNK CPT STEM

Description of Event or Problem

IT WAS REPORTED THE PATIENT UNDERWENT A REVISION APPROXIMATELY 3 YEARS AND 3 MONTHS POST-IMPLANTATION DUE TO INSTABILITY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

Additional Manufacturer Narrative

(B)(4). PROPOSED COMPONENT CODE: MECHANICAL (G04) - STEM. G2: FOREIGN - EVENT OCCURRED IN AUSTRALIA. 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 3500A WILL BE SUBMITTED.