BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-HINGE FIXED TIBIAL INSERT SIZE 1/20MM

    MDR report key: 10974217 · Received December 9, 2020

    Report

    Report Number
    3005180920-2020-00884
    Event Type
    Injury
    Date Received
    December 9, 2020
    Date of Event
    November 13, 2020
    Report Date
    December 9, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825019
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25 NOVEMBER 2020 LOT 161838: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-APR-2016. EXPIRATION DATE: 28.MAR.2021. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    WASHOUT OUT AND PLOY SWAP ALMOST 2 MONTHS AFTER PRIMARY SINCE THE WOUND DID NOT HEAL. INFECTION WAS CONFIRMED, THE PATHOGEN WAS STREP ORALIS AND STREP MITIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445516 GMK-HINGE FIXED TIBIAL INSERT SIZE 1/20MM FIXED TIBIAL INSERT KRO MEDACTA INTERNATIONAL SA 02.09.0120H 161838 07630030825019

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention