BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HFN LH 130 DEG 9MM X 360MM

    MDR report key: 3051348 · Received April 10, 2013

    Report

    Report Number
    0001825034-2013-00926
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    BIOMET TRAUMA
    Product Code
    HSB
    PMA / PMN Number
    PK100238
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABILITY - THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET ORTHOPEDICS TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA TO PROVIDE RESULTS. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. DIMENSIONAL EVALUATION FOUND COMPONENT TO BE WITHIN APPROPRIATE DESIGN SPECIFICATION. EVALUATION OF THE EXPLANTED DEVICE FOUND EVIDENCE OF FATIGUE FRACTURE. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER ADVERSE EVENTS, IT STATES, "THE FOLLOWING ARE THE MOST FREQUENT ADVERSE EVENTS AFTER FIXATION WITH ORTHOPAEDIC SCREWS, PLATES, INTRAMEDULLARY NAILS, COMPRESSION HIP SCREWS, PINS AND WIRES: LOOSENING, BENDING, CRACKING OR FRACTURE OF THE COMPONENTS OR LOSS OF FIXATION IN BONE ATTRIBUTABLE TO NONUNION, OSTEOPOROSIS, MARKEDLY UNSTABLE COMMINUTED FRACTURES."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A FEMORAL FRACTURE REPAIR PROCEDURE WHERE A NAIL WAS IMPLANTED ON AN UNKNOWN DATE. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2013 TO REMOVE AND REPLACE THE NAIL AS IT HAD FRACTURED. THE NAIL FRACTURED AT THE POINT OF THE LAG SCREW WHICH CAUSED A PERIPROSTHETIC FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149281 HFN LH 130 DEG 9MM X 360MM ROD, FIXATION HSB BIOMET TRAUMA N/A DMDB2J

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R