STEMLESS HUMERAL HEAD 41MM X 13MM X ALPHA

Description of Event or Problem

IT WAS REPORTED THAT THIS PATIENT'S LEFT SHOULDER WAS REVISED. THE REVISION WAS DUE TO A FAILED ROTATOR CUFF AND WORN POLYETHYLENE. PATIENT ALSO HAD METALLOSIS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

Additional Manufacturer Narrative

D10 CONCOMITANT: 300-62-01 - STEMLESS HUM COMP INTEGRIP, CAGE, SIZE 1: (B)(6). H3: CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: H1 TYPE OF REPORTABLE EVENT: SERIOUS INJURY IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

Description of Event or Problem

IT WAS REPORTED THAT THIS PATIENT'S LEFT SHOULDER WAS REVISED. THE REVISION WAS DUE TO A FAILED ROTATOR CUFF AND WORN POLYETHYLENE. PATIENT ALSO HAD METALLOSIS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT HAD POLY DISASSOCIATION. IT WAS ALSO NOTED THAT PAIN HAD STARTED 2 MONTH PRIOR TO THE REVISION SURGERY.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B5, H6: COMPONENT CODE.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B3 H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D. THE REVISION REPORTED WAS LIKELY THE RESULT OF ROTATOR CUFF DEFICIENCIES AND PROSTHESIS WEAR OF THE POLYETHYLENE COMPONENT AS REPORTED. PROXIMAL HUMERAL COMPONENT MIGRATION RELATIVE TO THE GLENOID LIKELY CAUSED ECCENTRIC LOADING OF THE GLENOID COMPONENT, LEADING TO FULL-THICKNESS POLYETHYLENE WEAR AND FRACTURE. HOWEVER, ROTATOR CUFF FAILURE AND THE SERIES OF EVENTS CANNOT BE CONFIRMED AND POTENTIAL CONTRIBUTIONS OF USER OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.