BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY 8 IN SOLUTION STEM

    MDR report key: 1972511 · Received January 26, 2011

    Report

    Report Number
    1818910-2011-00893
    Event Type
    Injury
    Date Received
    January 26, 2011
    Date of Event
    June 19, 2008
    Report Date
    December 14, 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
    Health Professional
    N

    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

    PT CONTACTED DEPUY AS A RESULT OF THE ASR RECALL TO INITIATE A CLAIM. MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATE THAT THE PT WAS REVISED TO ADDRESS FEMORAL STEM LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY 8 IN SOLUTION STEM TOTAL HIP REPLACEMENT JDI DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention