BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET

    MDR report key: 146424 · Received January 2, 1998

    Report

    Report Number
    146424
    Event Type
    Injury
    Date Received
    January 2, 1998
    Date of Event
    September 14, 1997
    Report Date
    September 26, 1997
    Manufacturer
    BIOMET, INC.
    Product Code
    JDI
    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

    PT UNDERWENT REVISION OF RIGHT TOTAL HIP ARTHROPLASTY ON 09/08/1997 SECONDARY TO LOOSENING, WHICH WAS CAUSING PAIN. ON 09/14/1997, WHILE PT WAS REPOSITIONING IN BED, SHE STATED SHE FELT A "POP", ACCOMPANIED BY EXCRUCIATING PAIN. RETURNED TO SURGERY FOR CLOSED REDUCTION FOR CORRECTION OF DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET Implant HIP PROSTHESIS JDI BIOMET, INC. CENTRALIZERS; 12-162611 *
    2 BIOMET Implant HIP PROSTHESIS JDI BIOMET, INC. CENTRALIZERS; 162657 *
    3 BIOMET Implant HIP PROSTHESIS KWB BIOMET, INC. 163638-MODULAR *
    4 BIOMET Implant HIP PROSTHESIS KWY BIOMET, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R INC., RUTHERFORD NJ 07070.| 2 MM DALL-MILES CABLES LOT CODE: BXITAA HOWMEDICA,