BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HFN LH 125 DEG 11MM X 360MM

    MDR report key: 3329339 · Received September 6, 2013

    Report

    Report Number
    0001825034-2013-03638
    Event Type
    Injury
    Date Received
    September 6, 2013
    Date of Event
    August 6, 2013
    Report Date
    August 9, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HSB
    PMA / PMN Number
    PK100238
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS IT STATES, "LOOSENING, BENDING, CRACKING OR FRACTURE OF THE COMPONENTS OR LOSS OF FIXATION IN BONE ATTRIBUTABLE TO NONUNION, OSTEOPOROSIS, MARKEDLY UNSTABLE COMMINUTED FRACTURES." (NOTE: BIOMET, INC. ACQUIRED THE TRAUMA PRODUCT LINE FROM DEPUY ORTHOPAEDICS, INC. (¿DEPUY¿) ON JUNE 16, 2012 (¿CLOSING DATE¿). PURSUANT TO THE WRITTEN AGREEMENT BETWEEN BIOMET AND DEPUY, BIOMET AGREED TO BE RESPONSIBLE FOR REGULATORY REPORTING FOR EVENTS WHICH OCCURRED AFTER THE CLOSING DATE REGARDLESS OF THE ENTITY THAT ACTUALLY MANUFACTURED THE PRODUCT OR ACTUALLY SOLD THE PRODUCT TO THE HEALTHCARE PROVIDER. BECAUSE THE PRODUCT THAT IS THE SUBJECT MATTER WAS MANUFACTURED BEFORE THE CLOSING DATE, PLEASE BE ADVISED THAT THE SUBJECT PRODUCT WAS MANUFACTURED BY DEPUY AND NOT BIOMET.) DEPUY ALSO SOLD THE PRODUCT THAT IS THE SUBJECT MATTER TO THE HEALTHCARE PROVIDER INVOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A PARTIAL HIP ARTHROPLASTY ON (B)(6) 2011. SUBSEQUENTLY, PATIENT WAS REVISED TO A TOTAL HIP SYSTEM ON (B)(6) 2013, DUE TO A FRACTURED FEMORAL ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443128 HFN LH 125 DEG 11MM X 360MM ROD, FIXATION HSB BIOMET ORTHOPEDICS N/A DMDCHL

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R