BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK TIBIAL TRAY FIXED CEMENTED SIZE 2 RIGHT

    MDR report key: 4743186 · Received April 23, 2015

    Report

    Report Number
    3005180920-2015-00068
    Event Type
    Injury
    Date Received
    April 23, 2015
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2015: LOT 103878: (B)(4) STEMS PRODUCED AND RELEASED ON (B)(6) 2010. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) TIBIAS OF THE LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR ISSUE. ON (B)(6) 2015, WE RECEIVED THE CONFIRMATION THAT NO X-RAY NOR ITEMS WILL BE RECEIVED BACK. ON (B)(6) 2015, THE MEDICAL AFFAIRS DIRECTOR MADE THE FOLLOWING ANALYSIS: THIS TOTAL KNEE WAS REVISED AFTER 2.5 YEARS BECAUSE OF TIBIAL LOOSENING. NO X-RAYS, NO EXPLANTS, NO DESCRIPTION OF POSSIBLE EVENTS THAT MAY HAVE LED TO THE FAILURE. HENCE, IT IS NOT POSSIBLE TO DRAW ANY CONCLUSION. THERE ARE NO SPECIFIC INDICATIONS THAT THE ROOT CAUSE MAY BE DEVICE RELATED.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269136 GMK TIBIAL TRAY FIXED CEMENTED SIZE 2 RIGHT FIXED TIBIAL TRAY JWH

    Patients

    Seq Age Sex Outcome Treatment
    1