BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/11 MM L

    MDR report key: 11946154 · Received June 7, 2021

    Report

    Report Number
    3005180920-2021-00481
    Event Type
    Injury
    Date Received
    June 7, 2021
    Date of Event
    May 17, 2021
    Report Date
    June 7, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862649
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 21 MAY 2021: LOT 172792: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUL-2017. EXPIRATION DATE: 2022-06-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    3 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING LAXITY. THE SURGEON REVISED THE 11MM INSERT WITH A 13MM INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841447 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/11 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0511FL 172792 07630030862649

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention