BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIDENTIFIED ZIRCONIA HEAD 28MM + 8.5

    MDR report key: 3121621 · Received May 21, 2013

    Report

    Report Number
    1818910-2013-17419
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. FROM THE X-RAYS PROVIDED, THE HEAD DOES NOT APPEAR CENTERED WITHIN THE SHELL WHICH COULD INDICATE A DISLOCATION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    DUE TO THE DISLOCATIONS, A DECISION WAS MADE TO UNDERTAKE REVISION SURGERY AND IT WAS NOTED THE NECK OF THE FEMORAL COMPONENT WAS IMPINGING ON THE POLYETHYLENE LINER RESULTING IN DISLOCATION. DECISION WAS MADE TO EXCHANGE THE CUP AND TO CORRECT ORIENTATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225033 UNIDENTIFIED ZIRCONIA HEAD 28MM + 8.5 HEAD BALL KWA DEPUY ORTHOPAEDICS ZR212718

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention