BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR FMRL LAT 13.5X147

    MDR report key: 3619029 · Received February 10, 2014

    Report

    Report Number
    0001825034-2014-00664
    Event Type
    Injury
    Date Received
    February 10, 2014
    Date of Event
    July 22, 2008
    Report Date
    April 2, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY CORRECT INITIAL PROCEDURE DATE AND PRODUCT IDENTIFICATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: PRODUCT IDENTIFICATION/EXPIRY DATE. DATE IMPLANTED. MANUFACTURE DATE.

    Description of Event or Problem · 1

    BIOMET ORTHOPEDICS RECEIVED PRELIMINARY CLINICAL DATA REGARDING PATIENTS ENROLLED IN A CLINICAL STUDY. IT WAS REPORTED PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2008. SUBSEQUENTLY, AN ACUTE FRACTURED WAS NOTED. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE.

    Description of Event or Problem · 1

    BIOMET ORTHOPEDICS RECEIVED PRELIMINARY CLINICAL DATA REGARDING PATIENTS ENROLLED IN A CLINICAL STUDY. IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED ON THE RIGHT SIDE ON (B)(6) 2008 DUE TO AN ACUTE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87274 TAPERLOC POR FMRL LAT 13.5X147 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 514250

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R