BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/12MM

    MDR report key: 19085909 · Received April 11, 2024

    Report

    Report Number
    3005180920-2024-00199
    Event Type
    Injury
    Date Received
    April 11, 2024
    Date of Event
    March 18, 2024
    Report Date
    April 11, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817175
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20-MAR-2024: LOT 134132: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-DEC-2013. EXPIRATION DATE: 2018-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON 20-MAR-2024: GMK-REVISION 02.07.0683L REVISION FIXED TIBIAL TRAY CEMENTED SIZE 3 L (K123721) LOT 172154: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-AUG-2017. EXPIRATION DATE: 2022-07-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-REVISION 02.07.2403L FEMUR REVISION PS SIZE 3 L (K102437) LOT 154240: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-AUG-2015. EXPIRATION DATE: 2020-07-19. 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.

    Description of Event or Problem · 0

    AT ABOUT 6 YEARS AND 2 MONTHS AFTER THE PREVIOUS REVISION SURGERY (WHEN MEDACTA GMK REVISION COMPONENTS HAVE BEEN IMPLANTED), THE PATIENT CAME IN REPORTING STIFFNESS IN THE KNEE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO HINGE COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT HAD COMPETITOR COMPONENTS PRIOR TO MEDACTA REVISION COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695137 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/12MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 134132 07630030817175

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention