BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11/13 S-ROM 44MM M SPEC+0

    MDR report key: 2872694 · Received December 13, 2012

    Report

    Report Number
    1818910-2012-83708
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    May 25, 2011
    Report Date
    December 6, 2012
    Manufacturer
    DEPUY INTL., LTD.
    Product Code
    LPH
    PMA / PMN Number
    PK060031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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

    MAUDE REPORT (B)(4) VOLUNTARILY SUBMITTED BY PATIENT STATES THAT PATIENT WAS REVISED TO ADDRESS PAIN, LIMPING, AND POPPING AND LOCKING OF IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 11/13 S-ROM 44MM M SPEC+0 FEMORAL HEAD LPH DEPUY INTL., LTD. 2262929

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention