BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-HINGE 02.09.0312H FIXED TIBIAL INSERT SIZE 3/12MM

    MDR report key: 15977604 · Received December 14, 2022

    Report

    Report Number
    3005180920-2022-00925
    Event Type
    Injury
    Date Received
    December 14, 2022
    Date of Event
    November 18, 2022
    Report Date
    December 14, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825125
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 23 NOVEMBER 2022. LOT 2111972: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-DEC-2021. EXPIRATION DATE: 2026-NOV-17. 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.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453917 GMK-HINGE 02.09.0312H FIXED TIBIAL INSERT SIZE 3/12MM KNEE TIBIAL INSERT KRO MEDACTA INTERNATIONAL SA 02.09.0312H 2111972 07630030825125

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention