BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACETABULAR SHELL

    MDR report key: 3131275 · Received May 9, 2013

    Report

    Report Number
    3131275
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 26, 2013
    Report Date
    May 7, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    (B)(6) MALE ADMITTED WITH LEFT HIP PAIN FOR 5 DAYS. PATIENT HAD UNDERGONE LEFT TOTAL HIP REPLACEMENT ON (B)(6) 2013. PER RECORD, THE PATIENT HAD A HISTORY OF A VASCULAR NECROSIS TO THE LEFT HIP SECONDARY TO ARTHRITIS. INTRA-OP PER SURGEON, NOTED THE REPLACEMENT WAS DISLOCATED ANTERIORLY. ALSO, THAT WITH THE TRAUMA OF THE DISLOCATION, IT APPEARED THAT THE POSTERIOR PORTION OF THE GREATER TROCHANTER HAD FRACTURED AND SEPARATED FROM THE REST OF THE TROCHANTER. THE PATIENT UNDERWENT OPEN REDUCTION ANTERIOR DISLOCATION LEFT TOTAL HIP REPLACEMENT WITH OPEN REDUCTION INTERNAL FIXATION OF GREATER TROCHANTER FRACTURE, LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205197 ACETABULAR SHELL ORTHOPEDIC HARDWARE HRS BIOMET ORTHOPEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R