BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR (L) CLASSIC STEM

    MDR report key: 7456095 · Received April 24, 2018

    Report

    Report Number
    3010536692-2018-00500
    Event Type
    Injury
    Date Received
    April 24, 2018
    Report Date
    April 24, 2018
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WILL BE UPDATED ONCE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

    Additional Manufacturer Narrative · 1

    UPDATED ITEM NUMBER.

    Description of Event or Problem · 1

    ALLEGEDLY, AS REPORT, TRAUMATIC FEMORAL FRACTURE FROM PATIENT PLACING WASHING MACHINE ONTO A TRUCK AND SUBSEQUENT FALL. STEM AND HEAD REMOVED. SROM (SYNTHESE) & BIOLOX CERAMIC HEAD INSERTED. X-RAYS ATTACHED. AU VIGILANCE DECISION: NON-REPORTABLE- TGA EXEMPTION RULE 6 APPLIES: EXPECTED AND FORESEEABLE SIDE EFFECTS THAT ARE DOCUMENTED IN MFR IFU OR LABELING ARE NON-REPORTABLE. REFERENCE TO: ADVESE EFFECT 16 DOCUMENTED IN MFR IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298535 PROFEMUR (L) CLASSIC STEM HIP COMPONENT LPH MICROPORT ORTHOPEDICS INC. PHAS-5508 1727354

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention