BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY FEMUR CEMENTED SIZE 4 STD NARROW / RIGHT

    MDR report key: 6339349 · Received February 17, 2017

    Report

    Report Number
    3005180920-2017-00042
    Event Type
    Injury
    Date Received
    February 17, 2017
    Report Date
    February 17, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K122232
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE IN WHICH MEDACTA PRODUCTS WERE REMOVED IS UNKNOWN. ADDITIONAL INFORMATION RECEIVED ON 24 JANUARY 2017 AND INCLUDES: THE SURGERY WAS COMPLETED SUCCESSFULLY ON (B)(6) 2017. BATCH REVIEWS PERFORMED ON (B)(6) 2017. LOT 131952: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2013. EXPIRATION DATE: 2018-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THIS LOT HAVE BEEN ALREADY SOLD AND THIS IS THE SECOND SIMILAR EVENT REPORTED ON THE LOT. GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 RIGHT, CODE (B)(4), LOT. 132745 (K090988); (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2013. EXPIRATION DATE: 2018-06-30. 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. GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 3 / 10 MM, CODE (B)(4) LOT. 130892 (K090988); (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2013. EXPIRATION DATE: 2018-02-28. 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-PRIMARY PATELLA RESURFACING SIZE 1, CODE (B)(4), LOT. 131943 (K090988); (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2013. EXPIRATION DATE: 2018-05-31. 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. NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON REMOVED ALL MEDACTA PRODUCTS AND INPUT AN ANTIBIOTIC SPACER. THE PATHOGEN RELATED TO THE INFECTION IS UNKNOWN. THE SURGEON PLANS TO REMOVE THE ANTIBIOTIC SPACER AND RE-IMPLANT MEDACTA PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121357 GMK-PRIMARY FEMUR CEMENTED SIZE 4 STD NARROW / RIGHT KNEE FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 131952

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention