BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY FEMORAL HEAD

    MDR report key: 2921091 · Received January 17, 2013

    Report

    Report Number
    1818910-2013-01384
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    September 1, 2011
    Report Date
    December 18, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGED A NATURAL BIOLOGICAL CORROSION AND FRICTION WEAR CAUSED BY LARGE AMOUNTS OF TOXIC COBALT-CHROMIUM METAL IONS AND PARTICLES TO BE RELEASED INTO PATIENTS BLOOD AND TISSUE AND BONE SURROUNDING THE IMPLANT. PATIENT EXPERIENCED SEVERE PAIN, DISCOMFORT AND INFLAMMATION IN THE AREA OF THE IMPLANT. PATIENT ALSO EXPERIENCED DISLOCATION, DISARTICULATION, AND A SLIPPING FEELING IN THE HIP JOINT AND A SENSATION THAT THE PINNACLE DEVICE COULD NOT SUPPORT THEIR WEIGHT. **UPDATE** (B)(6) 2012- MEDICAL RECORDS AND PATIENT FACT SHEET RECEIVED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26089 UNKNOWN DEPUY FEMORAL HEAD FEMORAL HEAD KWA DEPUY INTERNATIONAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention