BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X25

    MDR report key: 14494641 · Received May 25, 2022

    Report

    Report Number
    3005180920-2022-00397
    Event Type
    Malfunction
    Date Received
    May 25, 2022
    Date of Event
    April 27, 2022
    Report Date
    July 15, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630040708098
    PMA / PMN Number
    K171058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 APRIL 2022: LOT 183703: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-AUG-2018. EXPIRATION DATE: 2023-AUG-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 29 APRIL 2022: REVERSE SHOULDER SYSTEM 04.01.0171 GLENOSPHERE 42XØ24.5 (K170452) LOT 174732: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-OCT-2017. EXPIRATION DATE: 2022-OCT-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. PICTURE ANALYSIS FROM MEDACTA SPINE R&D PROJECT MANAGER: THE PROVIDED PICTURES SHOW THAT THE GLENOSPHERE WAS DISLOCATED FROM THE GLENOID BASEPLATE AND THAT THE BLACK COLORED TISSUES SUGGEST DEVELOPMENT OF METALLOSIS. THE REVERSE LINER WAS FOUND MASSIVELY WORN OUT ON THE MEDIAL SIDE. VISUAL INSPECTION OF THE EXPLANTS IS REQUIRED TO PROCEED WITH THE ROOT CAUSE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    PIECES RETURNED ON JUNE 21ST 2022. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER. THE GLENOSPHERE BACK-SURFACE SHOWS TWO CIRCULAR SIGNS LIKELY DUE TO FRICTION WITH TWO PROTRUDING SCREWS. IT IS NOT POSSIBLE TO DETERMINE WHETHER THE SCREWS WERE NOT FULLY SEATED DURING THE PRIMARY SURGERY OR IF THEY BACKED OUT AFTER TIME. THE REVERSE LINER PRESENTS MASSIVE WEAR ON THE MEDIAL SIDE PRESUMABLY DUE TO FRICTION WITH THE SCAPULA. THE MEDIAL SIDE OF THE REVERSE METAPHYSIS IS DULL. MINOR BONE RESIDUALS ARE VISIBLE ON THE HA COATED PORTION. THE TAPER AND THE LATERAL SURFACE OF THE BASEPLATE ARE DAMAGED DUE TO REPETITIVE FRICTION WITH DISSOCIATED GLENOSPHERE.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN AND LIMITED MOTION. X-RAYS REVEALED THAT THE GLENOSPHERE DISASSOCIATED FROM THE GLENOID. AT 3 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE BASEPLATE, LINER, GEOSPHERE AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS HAD OBVIOUSLY BEEN AN ISSUE FOR A LONG TIME. NOTICE THE AMOUNT OF METALLOSIS, BONE RESORPTION AND WEAR OF COMPONENTS. THE GLENOSPHERE WAS FLOATING IN THE JOINT. THERE WAS NO WEAR OR DAMAGE TO THE GLENOSPHERE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2557326 REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X25 SHOULDER GLENOID BASEPLATE JWH MEDACTA INTERNATIONAL SA 04.01.0190 183703 07630040708098
    889496 REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X25 SHOULDER GLENOID BASEPLATE JWH MEDACTA INTERNATIONAL SA 04.01.0190 183703 07630040708098

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention