BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC MICROP FMRL 10.0MM

    MDR report key: 4211786 · Received October 29, 2014

    Report

    Report Number
    0001825034-2014-08426
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    September 29, 2014
    Report Date
    October 10, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK050441
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY RELATED TO THE EVENT. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS: " UNDESIRABLE SHORTENING OF LIMB. "

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(4) 2013. SUBSEQUENTLY, THE PATIENT WAS REVISED ON (B)(4) 2014 DUE TO LEG LENGTH DISCREPANCY. DURING THE PROCEDURE, THE SURGEON HAD TO CUT A HOLE IN THE FEMUR TO GET THE STEM OUT. THE STEM, HEAD AND LINER WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691970 TAPERLOC MICROP FMRL 10.0MM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 405010

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R