BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/17MM

    MDR report key: 10481248 · Received September 2, 2020

    Report

    Report Number
    3005180920-2020-00556
    Event Type
    Injury
    Date Received
    September 2, 2020
    Date of Event
    August 3, 2020
    Report Date
    September 2, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817991
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 06 AUGUST 2020: LOT 172167: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JUL-2017. EXPIRATION DATE: 2022-06-20. 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

    THE PATIENT CAME IN REPORTING INSTABILITY DUE TO THE POLY BEING LAX IN FLEXION. THE CAUSE OF THE LAX POLY IS UNKNOWN. THE SURGEON REVISED THE LINER WITH A HIGHER ONE (26MM) 4 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949052 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/17MM FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.07.0417SCF 172167 07630030817991

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention