BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUS

    MDR report key: 3574436 · Received January 14, 2014

    Report

    Report Number
    9613369-2014-00001
    Event Type
    Injury
    Date Received
    January 14, 2014
    Date of Event
    January 8, 2014
    Report Date
    April 29, 2014
    Manufacturer
    SMITH&NEPHEW, INC
    Product Code
    LPF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THE DEVICE INVOLVED IN THE REVISION SURGERY WAS NOT A PRODUCT OF SMITH&NEPHEW, INC. AS A RESULT, THIS MEDWATCH WAS FILED IN ERROR. BASED ON THE INFORMATION PROVIDED, A SMITH&NEPHEW DEVICE DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, NOR HAS IT BEEN IMPLICATED BY THE PHYSICIAN. IN ADDITION, THE INFORMATION PROVIDED DOES NOT REASONABLY SUGGEST THAT A SMITH&NEPHEW DEVICE MALFUNCTIONED. THEREFORE, UNDER THE REGULATIONS SET FORTH UNDER 21 CFR 803, IT IS CONCLUDED THAT THIS IS NOT A REPORTABLE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO IMPLANT BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37063 PLUS CERAMIC BALL FEM HEAD LPF SMITH&NEPHEW, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R