BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER

    MDR report key: 77446 · Received March 18, 1997

    Report

    Report Number
    32446-1997-00001
    Event Type
    Injury
    Date Received
    March 18, 1997
    Date of Event
    January 30, 1997
    Report Date
    March 18, 1997
    Manufacturer
    ZIMMER, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT REPORTED THAT WHEN SHE WAS RISING FROM A CHAIR, THE HEADS SHEARED OFF THE FOUR BONE SCREWS, CAUSING THE TUBE AND PLATE TO BECOME LOOSE. OTHER DEVICES USED: 1. 3 EACH 00-2319-043-00 SCREWS LOT # UNK, 2. 1 EACH 00-1181-010-40 LAG SCREW LOT #73375600, 3. 1 EACH 00-1199-135-04 TUBE & PLATE, LOT #76690200.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER Implant BONE SCREWS HWC ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention