BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIGLIANI/FLATOW COMPLETE SHOULDER

    MDR report key: 1000173 · Received February 15, 2008

    Report

    Report Number
    3005751028-2008-00002
    Event Type
    Injury
    Date Received
    February 15, 2008
    Date of Event
    January 22, 2008
    Report Date
    February 15, 2008
    Manufacturer
    ZIMMER TMT
    Product Code
    KYM
    Removal / Correction Number
    Z-023/030-6
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANT WAS RETAINED BY THE SURGEON AND NOT RETURNED FOR EVALUATION. THE DESCRIPTION OF THE EVENT INDICATES THAT THE PHYSICAL TRAUMA EXPERIENCED BY THE PATIENT CAUSED THE DEVICE TO FRACTURE.

    Description of Event or Problem · 1

    THE PATIENT SUFFERED A TRAUMATIC EVENT, WHEN HE ATTEMPTED TO CATCH A FALLING TABLE, WHICH WEIGHED GREATER THAN 200 LBS. RADIOGRAPHIC EVALUATION OF THE PATIENT SUBSEQUENT TO THE EVENT REVEALED THAT THE IMPLANT HAD FRACTURED. THE PATIENT WAS SUCCESSFULLY REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIGLIANI/FLATOW COMPLETE SHOULDER GLENOID COMPONENT KYM ZIMMER TMT

    Patients

    Seq Age Sex Outcome Treatment
    1 YR