BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET

    MDR report key: 505938 · Received January 9, 2004

    Report

    Report Number
    505938
    Event Type
    Injury
    Date Received
    January 9, 2004
    Date of Event
    October 26, 2003
    Report Date
    January 9, 2004
    Manufacturer
    BIOMET
    Product Code
    KWY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT TREATED WITH SURGERY FOR RIGHT HIP FEMORAL NECK FRACTURE WITH A CEMENTED HEMI-ARTHROPLASTY USING A BIPOLAR PROSTHESIS. PATIENT WAS DISCHARGED ON DAY 3 POST-OP. EIGHT DAYS LATER, PATIENT READMITTED WITH A POSSIBLE RIGHT HIP DISLOCATION. A CLOSED REDUCTION WAS ATTEMPTED UNDER GENERAL ANESTHESIA. A SHIFT WITH AN APPARENT RELOCATION OF THE HIP WAS NOTED. X-RAY SHOWED A DISSOCIATION BETWEEN THE BIPOLAR COMPONENTS. THERE WAS NO EVIDENCE OF A FEMORAL SHAFT FRACTURE. AN OPEN REDUCTION WAS PERFORMED, THE DISSOCIATED BIPOLAR AND OTHER WERE REMOVED AND REPLACED WITH NEW ONES. PT WAS TREATED FOR A WOUND INFECTION, DISCHARGED THE FOLLOWING MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET RINGLOC BI-POLAR FEMORAL CUP KWY BIOMET 11-165220 713980

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention ALSO IMPLANTED IN 2003: BIOMET FEMORAL STEM#| 162901, LOT# 165450, HEAD# 163662, LOT# 122900.