BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX

    MDR report key: 4202619 · Received October 27, 2014

    Report

    Report Number
    1020279-2014-00667
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 20, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LPF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683428 BIOLOX FEMORAL COMPONENT LPF SMITH & NEPHEW, INC. 09DT30512A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization