BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM GLENOID BASEPLATE 24.5X25

    MDR report key: 10904260 · Received November 25, 2020

    Report

    Report Number
    3005180920-2020-00824
    Event Type
    Injury
    Date Received
    November 25, 2020
    Date of Event
    November 2, 2020
    Report Date
    November 25, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706391
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 06-NOV-2020: LOT 1904753: 80 ITEMS MANUFACTURED AND RELEASED ON 18-DEC-2019. EXPIRATION DATE: 08-DEC-2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 51 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: DURING IMPLANTATION OF RSA IN A (B)(6) PATIENT, A FRACTURE WAS CREATED ON THE GLENOID BONE AND SUFFICIENT STABILITY COULD NOT BE ACHIEVED. CEMENT WAS USED AND THE SURGERY TERMINATED, BUT SOON AFTERWARDS THE GLENOID COMPONENT FELL OFF THE BONE AND REVISION WAS NECESSARY. THIS PROBLEM WAS NOT CAUSED BY A DEVICE DEFICIENCY.

    Description of Event or Problem · 1

    (B)(6) PATIENT OPERATED WITH REVERSE SHOULDER SYSTEM ON (B)(6) 2020. INTRA-OPERATIVELY, THE GLENOID CONSTRUCT WAS UNSTABLE, THE GLENOID BONE FRACTURED AND THE BASEPLATE MOBILIZED COMPLETELY. THE FRACTURE AND THE BASEPLATE WERE CEMENTED IN ORDER TO FIX THE ISSUE. AFTER 3 DAYS, THE BASEPLATE MOBILIZED AGAIN, THE PATIENT WAS THEN REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1368123 REVERSE SHOULDER SYSTEM GLENOID BASEPLATE 24.5X25 REVERSE SHOULDER BASEPLATE PHX MEDACTA INTERNATIONAL SA 04.01.0152 1904753 07630040706391

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention