BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY ACETABULAR SYSTEM SHELL WITH CLUSTER HOLES POROUS

    MDR report key: 1073701 · Received July 1, 2008

    Report

    Report Number
    1822565-2008-00377
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Date of Event
    May 28, 2008
    Report Date
    June 6, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE RIGID METAL NOTCHES ON THE IMPLANT HAD TORN THE POLY BAG DURING DISTRIBUTION. IN 2005, THE PACKAGING WAS REVISED. THE REVISION INCLUDED ADDING A THICK, ABRASIVE RESISTANT POLY BAG. A VACUUM IS PULLED ON THE BAG BEFORE SEALING, LIMITING THE MOVEMENT OF THE IMPLANT. EVALUATION: THE POLY BAG SHOWS ABRASION TYPE WEAR OF WHAT APPEARS TO BE THE OUTER DIAMETER OF THE SHELL. DEVICE HISTORY RECORDS INDICATE DEVICE MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON DIDN'T USE THIS DEVICE BECAUSE THE POLY BAG WRAPPING IT HAD TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY ACETABULAR SYSTEM SHELL WITH CLUSTER HOLES POROUS HIP PROSTHESIS KWB ZIMMER, INC. NA 53385700

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK