BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM LONG HUMERAL DIAPHYSIS - L160 - 6

    MDR report key: 15000061 · Received July 13, 2022

    Report

    Report Number
    3005180920-2022-00527
    Event Type
    Injury
    Date Received
    July 13, 2022
    Date of Event
    June 17, 2022
    Report Date
    July 13, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWS
    UDI-DI
    07630040733922
    PMA / PMN Number
    K192967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28-JUN-2022. LOT 1900924: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JUL-2019. EXPIRATION DATE: 2024-06-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 9 DAYS AFTER THE PRIMARY SURGERY (OF MEDACTA PRODUCTS), THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE HUMERAL DIAPHYSIS COMPONENT AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE DIAPHYSIS, METAPHYSIS, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAS A PREVIOUS REVISION SURGERY OF COMPETITOR'S PRODUCTS: TORNIER REVERSE 6+ YEARS POST PRIMARY THAT WAS MISSING A LARGE PORTION OF THE PROXIMAL HUMERUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1715750 REVERSE SHOULDER SYSTEM LONG HUMERAL DIAPHYSIS - L160 - 6 SHOULDER HUMERAL DIAPHYSIS KWS MEDACTA INTERNATIONAL SA 04.01.0213 1900924 07630040733922

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention