BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R

    MDR report key: 19858759 · Received July 30, 2024

    Report

    Report Number
    3005180920-2024-00582
    Event Type
    Injury
    Date Received
    July 30, 2024
    Date of Event
    July 11, 2024
    Report Date
    July 30, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17 JULY 2024. LOT 171072: 30 ITEMS MANUFACTURED AND RELEASED ON 30-MAY-2017. EXPIRATION DATE: 2022-05-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 25 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 6 YEARS FROM PRIMARY THE SURGEON PREFORMED A WASHOUT AND POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245000 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 171072

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention