BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK

    MDR report key: 23070843 · Received September 17, 2025

    Report

    Report Number
    3005180920-2025-00869
    Event Type
    Injury
    Date Received
    September 17, 2025
    Date of Event
    August 25, 2025
    Report Date
    September 17, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971260979
    PMA / PMN Number
    K202022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28-AUGUST-2025: LOT: 2401812: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-03-2024 EXPIRATION DATE: 2029-03-11. 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. REVISION SURGERY WAS PERFORMED TO REPAIR THE TORN PATELLAR TENDON; THERE IS NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 0

    AT ABOUT 4 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A TORN PATELLA TENDON AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATELLA AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1635237 GMK GMK-SPHERE RESURFACING PATELLA E-CROSS - S1 JWH MEDACTA INTERNATIONAL SA 02.12.E001RP 2401812 07630971260979

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention