BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12/14 ARTICUL 40 MM M SPEC +5

    MDR report key: 1923645 · Received December 9, 2010

    Report

    Report Number
    1818910-2010-09590
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    DEPUY INT'L LTD
    Product Code
    LPH
    PMA / PMN Number
    K060031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    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 WAS REVISED TO ADDRESS CONTINUOUS HIP PAIN SINCE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12/14 ARTICUL 40 MM M SPEC +5 87LPH; 87JDI LPH DEPUY INT'L LTD NA 2606291

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention NA.