BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY LINER

    MDR report key: 1870371 · Received October 11, 2010

    Report

    Report Number
    1818910-2010-07606
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 5, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    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.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEPUY AS A RESULT OF THE ASR RECALL TO INITIATE A CLAIM. MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATE THAT THE PATIENT DID NOT HAVE ASR, BUT WAS REVISED TO ADDRESS POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY LINER TOTAL HIP REPLACEMENT JDI DEPUY ORTHOPAEDICS, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention