BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOD ENHCD INS 28/45 APR

    MDR report key: 286989 · Received July 26, 2000

    Report

    Report Number
    2935620-2000-00024
    Event Type
    Injury
    Date Received
    July 26, 2000
    Date of Event
    June 27, 2000
    Report Date
    June 27, 2000
    Manufacturer
    SULZER ORTHOPEDICS, INC.
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED: DR REMOVED AN "APR" ACETABULAR SHALL AND INSERT FROM A PT. THE POLYTHYLENE INSERT WAS APPARENTLY "IN PIECES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOD ENHCD INS 28/45 APR HIP PROSTHESIS KWB SULZER ORTHOPEDICS, INC. NA 30474

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Hospitalization| R 1449198) (06/2000).| 7210-28-000 COCR HD 12/14 NECK NEU 28MM| 7354-02-100 NATURAL-HIP POR COLLES STM RT SZ 0| 4310-02-045 12 SLOT SHELL SZ 45MM APR II (LOT #| (LOT# 1243448) (6/2000)| (LOT#1143081) (6/2000)