BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION 02.07.0685L REVISION FIXED TIBIAL TRAY CEMENTED SIZE 5 L

    MDR report key: 16240566 · Received January 25, 2023

    Report

    Report Number
    3005180920-2022-01002
    Event Type
    Injury
    Date Received
    January 25, 2023
    Date of Event
    December 26, 2022
    Report Date
    January 25, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819407
    PMA / PMN Number
    K123721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 28-DEC-2022. LOT 2201252: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JUN-2022. EXPIRATION DATE: 2027-06-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT HAD A PRIMARY SURGERY WITH COMPETITOR COMPONENTS AND WAS REVISED TO MEDACTA GMK-REVISION SYSTEM ON (B)(6) 2022. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1470411 GMK-REVISION 02.07.0685L REVISION FIXED TIBIAL TRAY CEMENTED SIZE 5 L KNEE REVISION FIXED TIBIAL TRAY CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.0685L 2201252 07630030819407

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention