BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELF CENT HIP 40X28 RUST

    MDR report key: 3233578 · Received July 18, 2013

    Report

    Report Number
    1818910-2013-21538
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWY
    PMA / PMN Number
    PK812672
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATE: VISUAL EXAMINATION OF THE RETURNED COMPONENT FINDS NOTHING OUTWARD TO SUGGEST PRODUCT ERROR. A REVIEW OF THE DEVICE HISTORY RECORDS AND STERILIZATION CERTIFICATIONS DID NOT REVEAL ANY RELATED DEVIATIONS OR ANOMALIES. FOLLOW-UP FOR ADDITIONAL EVENT INFORMATION WAS CONDUCTED UTILIZING WORK INSTRUCTION WI-7915 APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. 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.

    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

    PATIENT WAS REVISED TO ADDRESS INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332983 SELF CENT HIP 40X28 RUST FEMORAL HEAD KWY DEPUY ORTHOPAEDICS, INC. FJ2E51

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention