BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L TINBN COATED

    MDR report key: 17412889 · Received July 28, 2023

    Report

    Report Number
    3005180920-2023-00598
    Event Type
    Injury
    Date Received
    July 28, 2023
    Date of Event
    July 14, 2023
    Report Date
    July 28, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030821806
    PMA / PMN Number
    K202684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18 JULY 2023 LOT 2113382: 15 ITEMS MANUFACTURED AND RELEASED ON 08-FEB-2022. EXPIRATION DATE: 2027-JAN-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 13 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICE RECEIVED BATCH REVIEW PERFORMED ON 18 JULY 2023: GMK-SPHERE 02.12.0723L FEMORAL COMPONENT SPHERE TINBN COATED SIZE 3+ L (K202684) LOT 2118648: 25 ITEMS MANUFACTURED AND RELEASED ON 12-MAY-2022. EXPIRATION DATE: 2027-MAY-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 20 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    ABOUT 8 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT REPORTING DIFFICULTIES WITH RANGE OF MOTION. AN ALLERGIC RESPONSE IS SUSPECTED, BUT THE PATIENT DENIES ANY RASHES OR ITCHING IN THE AREA. THE SURGEON HAS NO PLANS TO REVISE THE PATIENT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1968390 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L TINBN COATED KNEE TIBIAL TRAY CEMENTED JWH MEDACTA INTERNATIONAL SA 2113382 07630030821806

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention