UNKNOWN ANATOMIC SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT WHO RECEIVED A COMPREHENSIVE CONVERTIBLE GLENOID IMPLANT APPROXIMATELY SIX (6) YEARS AGO EXPERIENCED POLYETHYLENE-BEARING WEAR AND THINNING, RESULTING IN AUDIBLE SQUEAKING POST-IMPLANTATION. THE POLYETHYLENE LINER REPORTEDLY WORE THROUGH COMPLETELY, RESULTING IN METAL-ON-METAL ARTICULATION BETWEEN THE IMPLANT COMPONENTS AND SIGNIFICANT METALLIC DEBRIS WITHIN THE JOINT (METALLOSIS). THE PATIENT UNDERWENT REVISION SURGERY, DURING WHICH THE DAMAGED COMPONENTS WERE REMOVED, SIGNIFICANT TISSUE DEBRIDEMENT WAS PERFORMED, AND THE SHOULDER WAS CONVERTED FROM AN ANATOMIC TO A REVERSE CONFIGURATION.

Additional Manufacturer Narrative

(B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE THE ASSOCIATED REPORTS REFERENCED WITH APPLICABLE CONCOMITANT PRODUCTS BELOW IN THE D10 NARRATIVE. D10: CONCOMITANT MEDICAL PRODUCTS, PART (LOT): - UNKNOWN GLENOID POLY BASE (UNKNOWN). H6: PROPOSED ANNEX G CODE: MECHANICAL (G04) - HEAD. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. 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.