BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 21855128 · Received April 17, 2025

    Report

    Report Number
    3005180920-2025-00312
    Event Type
    Injury
    Date Received
    April 17, 2025
    Date of Event
    March 25, 2025
    Report Date
    April 17, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819926
    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 01-APR-2025 LOT 1902690: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-AUG-2019. EXPIRATION DATE: 27-JUL-2024. 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. ADDITIONAL DEVICES INVOLVED: GMK-SPHERE 02.12.0004L FEMORAL COMPONENT SPHERE CEMENTED SIZE 4 (K121416) LOT 188178: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-DEC-2018. EXPIRATION DATE: 09-DEC-2023. 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 02.12.0510FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L (K121416) LOT 1900380: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAY-2019. EXPIRATION DATE: 21-APR-2024. 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 5 YEARS AND 2 MONTHS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30608 GMK PRIMARY TOTAL KNEE SYSTEM GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L JWH MEDACTA INTERNATIONAL SA 02.07.1205L 1902690 07630030819926

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention