BEUDAMED
    FDA Adverse Event Death Summary report: N

    MALLORY/HEAD 60-70MM CLAW CONNECTOR

    MDR report key: 196681 · Received November 10, 1998

    Report

    Report Number
    MW1014943
    Event Type
    Death
    Date Received
    November 10, 1998
    Date of Event
    October 6, 1998
    Report Date
    November 2, 1998
    Manufacturer
    BIOMET, INC.
    Product Code
    JDQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED ON 10/06/98 WITH DIAGNOSIS OF INFECTED NONUNION OF LEFT INTERTROCHANTERIC HIP FRACTURE. OPERATING ROOM PROCEDURE: REMOVAL OF CEMENT SPACER, IMPLANTATION LEFT HIP. HEMI-ARTHROPLASTY VS TOTAL HIP ARTHROPLASTY. POSTOPERATIVELY PT BECAME HYPOTENSIVE AND REQUIRED REINTUBATION WITH ASSISTED VENTILATION. PT SUDDENLY DEVELOPED CARDIAC ARRHYTHMIAS AND ARRESTED. RESUSCITATIVE EFFORTS WERE UNSUCCESSFUL AND THE PT EXPIRED AT 14:25.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLORY/HEAD 60-70MM CLAW CONNECTOR Implant TI 6AL 4V ALLOY JDQ BIOMET, INC. * 110620
    10 RING LOC BI-POLAR ACETABULAR CUP Implant 28MM IO/45MM O.O. CO-CR-MO/UHMUPE/TITANIUM ALLOY KWB BIOMET, INC. * 955780
    11 MODULAR HEAD COMPONENT Implant 28 MM HEAD DIAMETER KWY BIOMET, INC. * 346750
    2 MALLORY/HEAD MODULAR CALCAR DISTAL BOWED STEM W/SCREW/SLOTTE Implant TI 6AL 4V ALLOY KWY BIOMET, INC. * 445810
    3 MALLORY/HEAD MODULAR CALCAR PROXIMAL FEMORAL REPLACEMENT Implant POROUS COATED W/OBLONG BOLT HOLE 458 TI 6AL 4V ALLOY KWY BIOMET, INC. * 593030
    4 MALLORY/HEAD 50-60MM CLAW CONNECTOR Implant TI 6AL 4V ALLOY JDQ BIOMET, INC. * 246170
    5 COBALT CHROME TROCH GRIP Implant 2.0MM LARGE CO-CR-MO ALLOY IDQ BIOMET, INC. * 204660
    6 COBALT CHROME CABLE Implant 2.0 MM DIA X 750 MM LENGTH CO-CR-MO ALLOY JDQ BIOMET, INC. * 344810
    7 COBALT CHROME CABLE Implant 2.0MM DIA X 750 MM LENGTH CO-CR-MO ALLOY JDQ BIOMET, INC. * 419330
    8 MALLORY/HEAD OBLONG TROCHANTER BOLT Implant UH MUPE/TI 6AL 4V ALLOY HTN BIOMET, INC. * 593230
    9 MALLORY/HEAD TROCHANTER CLAW Implant LARGE 73MM LONG CO-CR-MO ALLOY JDQ BIOMET, INC. * 049310 9709

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death