BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY FEMUR PS CEMENTED SIZE 4 LEFT

    MDR report key: 6812709 · Received August 23, 2017

    Report

    Report Number
    3005180920-2017-00466
    Event Type
    Injury
    Date Received
    August 23, 2017
    Date of Event
    July 24, 2017
    Report Date
    August 23, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030820847
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON (B)(6) 2017. LOT 143728: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2014. EXPIRATION DATE: 2019-07-31. 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. GMK-PRIMARY FULL-PE PS TIBIAL COMPONENT SIZE 4/10, CODE (B)(4) APPS, LOT. 157694 (K131310); (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2016. EXPIRATION DATE: 2021-03-29. 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

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS ENTEROCOCCUS. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE TIBIAL COMPONENT AND THE FEMUR. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593224 GMK-PRIMARY FEMUR PS CEMENTED SIZE 4 LEFT CEMENTED KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 143728 07630030820847

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention