BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WRIGHT MEDICAL TECHNOLOGY

    MDR report key: 518952 · Received March 29, 2004

    Report

    Report Number
    518952
    Event Type
    Injury
    Date Received
    March 29, 2004
    Date of Event
    February 27, 2004
    Report Date
    March 25, 2004
    Manufacturer
    WRIGHT MEDICAL GROUP CO
    Product Code
    KWR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT REVISION OF DISLOCATED CUSTOM CONTAINED SCAPULAR HUMERAL PROSTHESIS. PT WAS DISCHARGED THREE DAYS LATER, WITH NO COMPLICATIONS, TO THEIR HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WRIGHT MEDICAL TECHNOLOGY CUSTOM TITANIUM SCAPULA WITH MODULAR 26MM COBALT HUMERAL HEA KWR WRIGHT MEDICAL GROUP CO CUSTOM 03342551

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention 61811001.| REF# 870-5512, LOT# 06223847, OLYMPIA TOTAL| HOWMEDICA-OSTEONICS FULL DOSE (CONTROL #RA1012)| REF#1700-2602, LOT# 120A 134582, SLR BIPOLAR CUP| SURGICAL SIMPLEX RADIOPAQUE,| BONE CEMENT-STRYKER:| INSERT FITS SHELLS 41-44MM, ID SIZE-26MM.| SHOULDER STEM, SIZE 12X125MM, STYLE S10S10HED.