BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FEMUR CEMENTED STD SIZE 5NARROW / RIGHT

    MDR report key: 7319831 · Received March 7, 2018

    Report

    Report Number
    3005180920-2018-00125
    Event Type
    Injury
    Date Received
    March 7, 2018
    Date of Event
    February 6, 2018
    Report Date
    March 7, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030820380
    PMA / PMN Number
    K122232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 06 MARCH 2018 LOT 150297: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 APRIL 2015. EXPIRATION DATE: 2020-02-29 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 4 R REFERENCE (B)(4) (K123721) LOT 150591: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 MARCH 2015. EXPIRATION DATE: 2020-02-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH A SIMILAR REPORTED EVENT. GMK-REVISION TIBIAL INSERT UC FIXED SIZE 4 / 17 MM REFERENCE (B)(4) (K090988) LOT 130893: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 APRIL 2013. EXPIRATION DATE: 2018-02-28 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    TWO YEARS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A KNEE INFECTION (B)(6) ((B)(6)). THE SURGEON REVISED SUCCESSFULLY THE PATIENT SWAPPING FEMUR, TIBIA AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162691 GMK-REVISION FEMUR CEMENTED STD SIZE 5NARROW / RIGHT FEMUR CEMENTED JWH MEDACTA INTERNATIONAL SA 150297 07630030820380

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention