BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOSPHERE 39X27

    MDR report key: 12217420 · Received July 23, 2021

    Report

    Report Number
    3005180920-2021-00630
    Event Type
    Injury
    Date Received
    July 23, 2021
    Date of Event
    July 12, 2021
    Report Date
    September 8, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706605
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D MANAGER: MILD CIRCUMFERENTIAL SIGNS ARE VISIBLE ON THE CONVEX BACK SURFACE OF THE GLENOSPHERE, PROBABLY DUE TO FRICTION WITH A PERIPHERAL GLENOID SCREW OR WITH THE BASEPLATE AFTER THE DISSOCIATION. THE GLENOSPHERE SCREW SHOWS CIRCULAR SCRATCHES ON THE OUTER SURFACE. THE LINER IS DAMAGED ON THE LOWER SIDE OF THE OUTER RIM LIKELY DUE TO FRICTION WITH THE SCAPULA AFTER THE GLENOSPHERE DISSOCIATION. THE PERIPHERAL GLENOID LOCKING SCREWS DO NOT SHOW ANY SIGNS OF DAMAGE. THE BASEPLATE AND THE REVERSE METAPHYSIS HAVE MINOR BONE RESIDUALS ON THE COATED AREAS. NO ACTION IS SUGGESTED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 20 JULY 2021: LOT 1910955: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAY-2020. EXPIRATION DATE: 2025-05-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: FEW MONTHS AFTER PRIMARY RSA THE GLENOSPHERE DETACHES FROM THE BASEPLATE AND REQUIRES REVISION SURGERY. FROM THE X-RAYS PROVIDED, IT APPEARS THAT THE GLENOSPHERE WAS NEVER ABLE TO REACH THE CORRECT SEATING POSITION ON THE BASEPLATE. THIS MAY BE DUE TO BASEPLATE FIXATION SCREWS PROTRUDING FROM THE BASEPLATE AND PREVENTING THE GLENOSPHERE TO REACH ITS FINAL POSITION, BUT THIS POSSIBILITY HAS NOT YET BEEN CONFIRMED. OTHER DEVICE INVOLVED IN THE EVENT: BATCH REVIEW PERFORMED ON 20 JULY 2021: REVERSE SHOULDER SYSTEM 04.01.0155 GLENOID BASEPLATE Ø27X25 (K170452) LOT 2005437: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-OCT-2020. EXPIRATION DATE: 2025-09-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY WAS PERFORMED 6 MONTHS AFTER PRIMARY FOLLOWING DISSOCIATION OF THE GLENOSPHERE FROM THE BASEPLATE. THE SURGEON REVISED THE GLENOSPHERE, THE BASEPLATE, THE SCREW, THE LINER, AND THE HUMERAL METAPHYSIS. THE BONE GRAFT WAS ALSO REMOVED DUE TO POOR CONSOLIDATION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119382 REVERSE SHOULDER SYSTEM GLENOSPHERE 39X27 GLENOSPHERE IMPLANT PHX MEDACTA INTERNATIONAL SA 04.01.0173 1910955 07630040706605

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention