BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIV 2-HOLE SHL 56MM LNR SZ 24

    MDR report key: 3000044 · Received March 12, 2013

    Report

    Report Number
    0001825034-2013-00577
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 14, 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
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DIMENSIONAL EVALUATION FOUND COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION. EXAMINATION OF RETURNED DEVICE WAS INCONCLUSIVE. 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, OR EXCESSIVE ACTIVITY."

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. 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, OR EXCESSIVE ACTIVITY."

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY IN (B)(6) 2010. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO CUP LOOSENING AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103074 UNIV 2-HOLE SHL 56MM LNR SZ 24 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 687020

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R