BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-HINGE FIXED TIBIAL INSERT SIZE 4/12MM

    MDR report key: 18957341 · Received March 22, 2024

    Report

    Report Number
    3005180920-2024-00131
    Event Type
    Injury
    Date Received
    March 22, 2024
    Date of Event
    February 22, 2024
    Report Date
    March 22, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825194
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28-FEB-2024: LOT 2237419: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-OCT-2022. EXPIRATION DATE: 2027-10-04. 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. ADDITIONAL COMPONENT REVISED: GMK-HINGE 02.09.HE12 GMK-HINGE POST EXTENSION 12 MM -TINBN COATED (K210010) LOT 2208573: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JUL-2022. EXPIRATION DATE: 2027-06-24. 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 1 MONTH AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED SUCCESSFULLY THE LINER AND HINGE POST EXTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2560090 GMK-HINGE FIXED TIBIAL INSERT SIZE 4/12MM KNEE TIBIAL INSERT KRO MEDACTA INTERNATIONAL SA 2237419 07630030825194

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention