BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 4 / 10 MM

    MDR report key: 19236177 · Received May 3, 2024

    Report

    Report Number
    3005180920-2024-00294
    Event Type
    Injury
    Date Received
    May 3, 2024
    Date of Event
    April 10, 2024
    Report Date
    May 3, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817663
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19 APRIL 2024: LOT 162471: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-JULY-2016. EXPIRATION DATE: 2021-07-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH OTHER 2 SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON 19 APRIL 2024: GMK-PRIMARY 02.07.1204L TIBIAL TRAY FIXED CEMENTED SIZE 4 L (K090988) LOT 1904218: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-OCT-2019. EXPIRATION DATE: 2024-10-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-PRIMARY 02.07.2004L FEMUR STD CEMENTED SIZE 4 L (K090988) LOT 1905179: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-OCT-2019. EXPIRATION DATE: 2024-09-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-PRIMARY 02.07.0034RP PATELLA RESURFACING SIZE 2 (K090988) LOT 1902821: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JUN-2019. EXPIRATION DATE: 2024-06-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 4 YEARS AND 2 MONTHS POST PRIMARY THE SURGEON REMOVED ALL COMPONENTS, PERFORMED A WASHOUT, AND REIMPLANTED PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277776 GMK-PRIMARY TIBIAL INSERT STD FIXED SIZE 4 / 10 MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 162471 07630030817663

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention