BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 21197088 · Received January 21, 2025

    Report

    Report Number
    3005180920-2024-01172
    Event Type
    Injury
    Date Received
    January 21, 2025
    Date of Event
    December 27, 2024
    Report Date
    January 21, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030815775
    PMA / PMN Number
    K113571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 30-DEC-2024: LOT 2242833: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JAN-2023. EXPIRATION DATE: 2027-12-12. 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. BATCH REVIEWS PERFORMED ON 30-DEC-2024: GMK-SPHERE 02.07.1204L TIBIAL TRAY FIXED CEMENTED SIZE 4 L (K090988) LOT 2207305: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUL-2022. EXPIRATION DATE: 2027-07-12. 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-SPHERE 02.12.0024L FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ L (K140826) LOT 2245092: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-FEB-2023. EXPIRATION DATE: 2028-01-25. 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 02.12.0410FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L (K121416) LOT 2304911: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-APR-2023. EXPIRATION DATE: 2028-04-09. 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. ROOT CAUSE: THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 4 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY. IT WAS NOT POSSIBLE TO ACHIEVE THE CORRECT BALANCE OF THE KNEE IN BOTH FLEXION AND EXTENSION. THE SURGEON REVISED ALL COMPONENTS TO COMPETITOR COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555711 GMK PRIMARY TOTAL KNEE SYSTEM GMK-SPHERE PATELLA RESURFACING SIZE 4 JWH MEDACTA INTERNATIONAL SA 02.07.0036RP 2242833 07630030815775

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention