BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 20964343 · Received December 18, 2024

    Report

    Report Number
    3005180920-2024-01036
    Event Type
    Injury
    Date Received
    December 18, 2024
    Date of Event
    November 18, 2024
    Report Date
    December 18, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    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 25-NOV-2024. LOT 2315162: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-SEP-2023. EXPIRATION DATE: 2028-08-29. 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. GMK-SPHERE 02.12.0006R FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 R (K121416) LOT 2312311: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-SEP-2023. EXPIRATION DATE: 2028-09-03. 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. GMK-SPHERE 02.12.E004RP PATELLA RESURFACING SIZE 4 E-CROSS (K202022) LOT 2315320: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-OCT-2023. EXPIRATION DATE: 2028-09-30. 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. GMK-SPHERE 02.12.E0510FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R E-CROSS (K202022) LOT 2318209: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-AUG-2023. EXPIRATION DATE: 2028-07-17. 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. 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 1 YEAR AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291900 GMK PRIMARY TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R JWH MEDACTA INTERNATIONAL SA 02.07.1205R 2315162

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention