BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET HIP FRACTURE FMRL

    MDR report key: 1051632 · Received May 22, 2008

    Report

    Report Number
    1825034-2008-00160
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 24, 2008
    Report Date
    April 24, 2008
    Manufacturer
    BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K953925
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT. A FAX WAS SENT TO INFORM THE USER FACILITY OF THE EVENT. IN THE EVENT THAT THE USER FACILITY SUBMITS A MEDWATCH REPORT, BIOMET WILL FORWARD A COPY TO FDA. EVAL OF RETURNED DEVICE FOUND IMPLANT DID NOT MEET DESIGN SPECS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT UNDERWENT TOTAL HIP ARTHROPLASTY IN 2008. SURGEON REAMED AND BROACHED THEN ATTEMPTED TO INSERT A 14MM IMPLANT; HOWEVER, IMPLANT SAT PROUD. SURGEON REAMED AND BROACHED AGAIN WITH THE SAME RESULTS. A 12MM STEM WAS CEMENTED TO COMPLETE THE PROCEDURE. AS A RESULT, THERE WAS APPROX ONE HR AND THIRTY (30) MIN DELAY IN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET HIP FRACTURE FMRL LZO BIOMET, INC. NA 033600

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other