BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 3884634 · Received June 19, 2014

    Report

    Report Number
    0001825034-2014-05644
    Event Type
    Injury
    Date Received
    June 19, 2014
    Report Date
    May 23, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK002757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN ORTHOPEDIC SALVAGE SYSTEM PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, ON (B)(6) 2014, PATIENT WAS MEASURED WITH A 15CM LEG DISCREPANCY. ADDITIONALLY, IT WAS NOTED THAT THE FEMORAL COMPONENT MIGRATED PROXIMALLY AND THE STEM PROTRUDED THROUGH THE GREATER TROCHANTER. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361075 UNKNOWN PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention