BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERIKA 02.07.1204L TIBIAL TRAY FIX CEMENTED S.4L

    MDR report key: 18111193 · Received November 10, 2023

    Report

    Report Number
    3005180920-2023-00862
    Event Type
    Injury
    Date Received
    November 10, 2023
    Date of Event
    October 12, 2023
    Report Date
    November 10, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819902
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6) 2023. LOT 2237762: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-DEC-2022. EXPIRATION DATE: 2027-11-22. 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. OTHER DEVICES INVOLVED: GMK-SPHERIKA 02.12.0411FL GMK-SPHERE TIBIAL INSERT - FLEX S4L - 11 MM (K140826) LOT 2112458: (B)(4)ITEMS MANUFACTURED AND RELEASED ON 14-OCT-2021. EXPIRATION DATE: 2026-09-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. GMK-SPHERIKA 02.12.KA05L GMK SPHERIKA FEMORAL COMPONENT S5L CEMENTED (K211004) LOT 2112573: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 3-NOV-2021. EXPIRATION DATE: 2026-10-20. 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.

    Description of Event or Problem · 0

    AT ABOUT 8 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND RE-IMPLANTED PERMANENT COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1939333 GMK-SPHERIKA 02.07.1204L TIBIAL TRAY FIX CEMENTED S.4L KNEE TIBIAL TRAY FIX CEMENTED JWH MEDACTA INTERNATIONAL SA 2237762 07630030819902

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention