BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR LAT FMRL 5.0X130

    MDR report key: 3115239 · Received May 16, 2013

    Report

    Report Number
    0001825034-2013-01530
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 19, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION INDICATES THAT HETEROTOPIC OSSIFICATION CAUSED THE EVENT BY CAUSING THE STEM TO LOOSEN. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 4 STATES, "LOOSENING OR MIGRATION OF THE IMPLANTS CAN OCCUR DUE TO LOSS OF FIXATION, TRAUMA, MALALIGNMENT, BONE RESORPTION, EXCESSIVE ACTIVITY."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2005. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO STEM LOOSENING FROM HETEROTOPIC OSSIFICATION. THE STEM, HEAD AND LINER WERE REMOVED AND REPLACED WITH BIOMET PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217985 TAPERLOC POR LAT FMRL 5.0X130 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 749830

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R