BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/10 MM L

    MDR report key: 11626179 · Received April 7, 2021

    Report

    Report Number
    3005180920-2021-00262
    Event Type
    Injury
    Date Received
    April 7, 2021
    Date of Event
    March 7, 2021
    Report Date
    April 7, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826733
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2021: LOT 2002755: 99 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2020. EXPIRATION DATE: 2025-05-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 60 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY WAS PERFORMED 4 WEEKS AFTER THE PRIMARY DUE TO SUSPECTED INFECTION. DAIR WAS PERFORMED AND THE INSERT SUCCESSFULLY REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527694 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 5/10 MM L TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0510FL 2002755 07630030826733

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention