BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACETABULAR REVISION SYSTEM

    MDR report key: 1652410 · Received March 31, 2010

    Report

    Report Number
    3005751028-2010-00016
    Event Type
    Malfunction
    Date Received
    March 31, 2010
    Date of Event
    March 4, 2010
    Report Date
    March 31, 2010
    Manufacturer
    ZIMMER TMT
    Product Code
    KWB
    Removal / Correction Number
    3005751028-03/24/2010-00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A CORRECTION AND REMOVAL ACTION AND BEEN INITIATED. ZIMMER, INC. IS PERFORMING A REMOVAL OF THE BALANCE OF UNUSED IMPLANTS, PER THE LOT SCOPE CONTAINED IN THE CANDR REPORT. ZIMMER TMT WILL DEVELOP AND TEST MODIFICATION TO THE IMPLANT PACKAGING . THIS MODIFICATION WILL DECREASE THE LIKELIHOOD OF A BREACH IN THE STERILE BARRIER.

    Description of Event or Problem · 1

    EVENT DETAIL: IT WAS REPORTED THAT THE INNER PACKAGING WAS NOT SEALED ON THE OUTER EDGE. THE IMPLANT WAS NOT USED. THE SURGERY WAS COMPLETED WITH ANOTHER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACETABULAR REVISION SYSTEM BUTTRESS AUGMENT KWB ZIMMER TMT NA 60770940

    Patients

    Seq Age Sex Outcome Treatment
    1