BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5

    MDR report key: 20188176 · Received September 11, 2024

    Report

    Report Number
    3005180920-2024-00723
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    August 14, 2024
    Report Date
    September 11, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706568
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 21 AUG 2024: LOT 2402049: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MAY-2024. EXPIRATION DATE: 2029-05-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED BATCH REVIEW PERFORMED ON 21 AUG 2024 REVERSE SHOULDER SYSTEM 04.01.0151 GLENOID BASEPLATE Ø24.5X15 (K170452) LOT 2403066: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-MAY-2024. EXPIRATION DATE: 2029-05-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 21 AUG 2024 REVERSE SHOULDER SYSTEM 64.01.9009 SF GLENOSPHERE SCREW LOT 2403624: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-APRIL-2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS MANAGER: DURING AN RSA THE GLENOSPHERE ROTATED WHILE TIGHTENING THE SCREW AND AT LEAST ONE SCREW BROKE AND THE GLENOID BONE FRACTURED. ACCORDING TO REPORT, IT'S UNKNOWN WHETHER THE FRACTURE OCCURRED DURING THE SEATING OF THE BASEPLATE OR THE GLENOSPHERE. IT MAY BE POSSIBLE THAT THE BONE QUALITY WAS VERY LOW AND TIGHTENING THE SCREWS EXCEEDED THE BONE STRENGTH. VISUAL INSPECTION PERFORMED BY MEDACTA R&D SHOULDER MANAGER: THE IMPLANTS DO NOT SHOW ANY SIGN OF DAMAGE. GIVEN THE INFORMATION AT HAND IT IS NOT POSSIBLE TO DETERMINE WHAT CAUSED THE GLENOID FRACTURE NOT WHEN IT OCCURRED. NO ACTION IS SUGGESTED.

    Description of Event or Problem · 0

    THE FIXATION GLENOSPHERE SCREW AND THE GLENOSPHERE ROTATED AT THE SAME TIME WHILE TIGHTENING AND THE GLENOID BONE FRACTURED. IT'S UNKNOWN WHETHER THE FRACTURE OCCURRED DURING THE SEATING OF THE BASEPLATE OR THE GLENOSPHERE. BONE GRAFT USED TO COMPLETE THE SURGERY, 27MM BASEPLATE AND 36XØ27 GLENOSPHERE SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1600804 REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5 SHOULDER GLENOSPHERE PHX MEDACTA INTERNATIONAL SA 2402049 07630040706568

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Female Other