BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PERITROCHANTERIC NAIL

    MDR report key: 4141146 · Received October 3, 2014

    Report

    Report Number
    0001825034-2014-07957
    Event Type
    Injury
    Date Received
    October 3, 2014
    Report Date
    September 9, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HSB
    PMA / PMN Number
    PK050118
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE: (B)(6). THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - UNKNOWN. EXPIRATION DATE - UNKNOWN. DATE EXPLANTED - UNKNOWN. INITIAL REPORTER - NAME UNKNOWN. MANUFACTURE DATE - UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PERITROCHANTERIC NAIL PROCEDURE FOR A LEFT HIP FRACTURE ON (B)(6) 2013. SUBSEQUENTLY, A REVISION PROCEDURE TOOK PLACE ON AN UNKNOWN DATE BECAUSE THE LOCKING SCREW MOVED WHEN THE LOCKING MECHANISM FAILED. THE PERITROCHANTERIC NAIL WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617742 UNKNOWN PERITROCHANTERIC NAIL ROD, FIXATION HSB BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R