BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOMET

    MDR report key: 206443 · Received January 13, 1999

    Report

    Report Number
    206443
    Event Type
    Death
    Date Received
    January 13, 1999
    Date of Event
    December 11, 1998
    Report Date
    January 12, 1999
    Manufacturer
    BIOMET INC.
    Product Code
    KWY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    11/28/1998 - ADMITTED (WITH) SUBCAPITAL FRACTURE RIGHT FEMUR. 11/30/1998 OPEN REDUCTION AND INTERNAL FIXATION, RIGHT HEMIARTHROPLASTY. 12/4/1998-PERONEAL NERVE PALSY RIGHT; RIGHT FOOT DROP. DISCHARGED 12/5/1998 - TO EMERGENCY DEPT WITH BLEEDING FROM HIP INCISION. DISCHARGED. 12/11/1998- READMITTED COLD, CYANOTIC TOES & ABSENT PULSES RIGHT FOOT; EXCESSIVE BLEEDING, SEROSANGUINAS DRAINAGE HIP INCISION SITE. 12/14/1998-RETURN TO SURGERY; ATTEMPTED CLOSED REDUCTION DISLOCATED RIGHT BIPOLAR, PROSTHESIS; PROSTHESIS DISASSOCIATED. 12/16/1998-RETURN TO SURGERY, OPEN REDUCTION AND INTERNAL FIXATION & REPLACEMENT OF CUP PORTION PROSTHESIS. REPLACEMENT: BIOMET LOT 807420, 28 MM IO/58 MM OO. 12/17/1998-RIGHT SIDED WEAKNESS, DIMINISHED MENTAL STATUS 12/19/1998 - EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET Implant RING LOC BI-POLAR FEMORAL CUP KWY BIOMET INC. 9701 940130

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| R BIOMET MODULAR HEAD COMPONENT, LOT 819630, 28 MM| HEAD, STANDARD NECK TYPE I TAPER.