AVANTAGE CMNTD SHELL SS 44MM

Additional Manufacturer Narrative

(B)(4). D-4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO 00880304524309. D10: 802202802 LOT 3237211 FEMORAL HEAD 12/1400811400000. 00811400000 LOT 66134357 CPT 12/14 STEM SIZE 0 COCR. 110031009 LOT 66528789 28MM I.D. 38MM O.D. SIZE C BEARING. G2: FOREIGN - EVENT OCCURRED IN AUSTRALIA. G-4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K121874. 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.

Description of Event or Problem

IT WAS REPORTED THAT APPROXIMATELY FOUR MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A LEFT HIP REVISION DUE TO PERIPROSTHETIC FRACTURE. REVIEW OF X-RAY IDENTIFIED DISLOCATION OF THE LEFT HIP. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.