BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L

    MDR report key: 15072644 · Received July 21, 2022

    Report

    Report Number
    3005180920-2022-00535
    Event Type
    Injury
    Date Received
    July 21, 2022
    Date of Event
    June 21, 2022
    Report Date
    July 21, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030827136
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22-JUN-2022: LOT 2012081: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-MAY-2021. EXPIRATION DATE: 2026-APR-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 22-JUN-2022: GMK-SPHERE 02.12.0004L FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 L (K121416) LOT. 2001634. LOT 2001634: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JUN-2020. EXPIRATION DATE: 2025-05-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 10 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIAL TRAY AND FEMORAL COMPONENT. THE SURGEON REVISED THE TIBIAL TRAY, FEMORAL COMPONENT AND POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1718736 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 02.12.T3I4L 2012081 07630030827136

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention