BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 21917680 · Received April 28, 2025

    Report

    Report Number
    3005180920-2025-00331
    Event Type
    Injury
    Date Received
    April 28, 2025
    Date of Event
    April 1, 2025
    Report Date
    April 25, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819933
    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 07-APR-2025: LOT 2210940: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-SEP-2022. EXPIRATION DATE: 29-AUG-2027. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED BATCH REVIEW PERFORMED ON 07-APR-2025 GMK-SPHERIKA 02.12.0510FR TIBIAL INSERT FIXED SPHERE FLEX #5/10 MM R (K121416) LOT 2110152A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-OCT-2021. EXPIRATION DATE: 10-SEP-2026. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERIKA 02.12.KA06R FEMORAL COMPONENT SPHERIKA CEMENTED S6R (K211004) LOT 2203787: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-JUN-2022. EXPIRATION DATE: 22-MAY-2027. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2025, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED ALL COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429447 GMK PRIMARY TOTAL KNEE SYSTEM GMK-SPHERIKA TIBIAL TRAY FIXED CEMENTED SIZE 5 R JWH MEDACTA INTERNATIONAL SA 02.07.1205R 2210940 07630030819933

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Required Intervention