BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 3201157 · Received July 2, 2013

    Report

    Report Number
    1818910-2013-20348
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    November 30, 2011
    Report Date
    June 4, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE REPORTED PART AND LOT CODE COMBINATION. THE PART AND LOT CODE COMBINATION WAS NOT PROVIDED FOR THE FEMORAL HEAD, ACETABULAR CUP, AND FEMORAL STEM. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    UPON MEDICAL RECORDS REVIEW BY A MEDICAL PROFESSIONAL, ADDITIONAL OPERATIVE NOTES INDICATED THAT THE PATIENT SUFFERED FROM A MALPOSITIONED CUP AND STEM, DISLOCATION, METALLOSIS, AND A FRACTURED LINER. THE METALLOSIS WAS CAUSED BY WEAR BETWEEN THE LINER AND CUP, DUE TO THE FRACTURED LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301618 UNKNOWN HIP FEMORAL HEAD FEMORAL HEAD KWY DEPUY ORTHOPAEDICS INC US UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention