BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 22726224 · Received August 6, 2025

    Report

    Report Number
    3005180920-2025-00750
    Event Type
    Injury
    Date Received
    August 6, 2025
    Date of Event
    July 17, 2025
    Report Date
    August 6, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030815737
    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 29 JULY 2025: GMK-SPHERE 02.07.0033RP PATELLA RESURFACING SIZE 1 (K090988) LOT 186273: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-OCT-2018. EXPIRATION DATE: 2023-09-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.07.1202L TIBIAL TRAY FIXED CEMENTED SIZE 2 L (K090988) LOT 187273: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-OCT-2018. EXPIRATION DATE: 2023-09-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0022L FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ L (K140826) LOT 183441: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JULY-2018. EXPIRATION DATE: 2023-06-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0211FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/11 MM L (K140826) LOT 174781: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-NOV-2017. EXPIRATION DATE: 2022-10-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ROOT CAUSE: 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

    AT ABOUT 6 YEARS 6 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1365536 GMK PRIMARY TOTAL KNEE SYSTEM PATELLA RESURFACING SIZE 1 JWH MEDACTA INTERNATIONAL SA 02.07.0033RP 186273 07630030815737

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention