BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOBLOCK ACETABULAR CUP

    MDR report key: 1295067 · Received January 16, 2009

    Report

    Report Number
    3005751028-2009-00005
    Event Type
    Injury
    Date Received
    January 16, 2009
    Date of Event
    December 15, 2008
    Report Date
    January 16, 2009
    Manufacturer
    ZIMMER TMT
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACETABULAR CUP'S PACKAGE INSERT STATES THAT ZIMMER HAS NOT TESTED THE SAFETY OR EFFECTIVENESS OF THIS DEVICE FOR USE IN COMBINATION WITH NON-ZIMMER PRODUCT OR COMPONENT. A REVIEW OF THE IMPLANT'S DEVICE HISTORY RECORD INDICATES THAT IT WAS MANUFACTURED TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IN 2003, A 52 MM TM MONOBLOCK ACETABULAR CUP WAS IMPLANTED WITH A DEPUY AML STEM 13.5MM AND 25MM +5 HEAD. A TRAUMATIC EVENT OCCURRED APPROXIMATELY 3.5 YEARS POST-IMPLANTATION. THIS PATIENT WAS REVISED TO RECURRENT DISLOCATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOBLOCK ACETABULAR CUP ACETABULAR CUP KWB ZIMMER TMT 70431200

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention