BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY ACETABULAR SYSTEM SHELL SPIKED POROUS

    MDR report key: 1894605 · Received May 14, 2010

    Report

    Report Number
    2648920-2010-00019
    Event Type
    Malfunction
    Date Received
    May 14, 2010
    Date of Event
    November 13, 2006
    Report Date
    January 29, 2007
    Manufacturer
    ZIMMER
    Product Code
    LPH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVAL: THE PRODUCT STATED IN THE COMPLAINT WAS NOT RETURNED FOR EVAL, THEREFORE THE EXACT CONDITION CANNOT BE ASCERTAINED. THE MANUFACTURING RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING INDICATING THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. EXEMPTION: (B)(4). TOTAL OF EVENTS: 13. REASON FOR EXEMPTION: THIS MDR IS BEING SUBMITTED LATE, AS THIS ISSUE WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINT FILES.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A PROTRUDING FIBER METAL STUNG THE SURGEON'S THUMB, AFTER CUTTING THAT PART OUT HE THEN IMPLANTED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY ACETABULAR SYSTEM SHELL SPIKED POROUS HIP IMPLANT LPH ZIMMER NA 60349472

    Patients

    Seq Age Sex Outcome Treatment
    1