BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALUMINA C-TAPER HEAD 32MM/0

    MDR report key: 1622631 · Received February 5, 2010

    Report

    Report Number
    9616680-2009-00691
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    October 19, 2006
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK STRYKER ORTHOPAEDICS
    Product Code
    LZO
    PMA / PMN Number
    K971409
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN STRYKER CORPORATION CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM (B)(6) 2006 TO (B)(6) 2008 WERE THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS WERE PART OF A RETROSPECTIVE SUMMARY REPORT BEING SUBMITTED UNDER EXEMPTION # (B)(4). THERE ARE 5 EVENTS ASSOCIATED WITH THIS EVENT TYPE (DEVICE DID NOT FUNCTION AS EXPECTED AND PRODUCT CODE LZO).

    Description of Event or Problem · 1

    DEVICE DID NOT FUNCTION AS EXPECTED. IT WAS REPORTED, "SIZE 32 +0 DEGREE ALUMINA HEAD BALL DID NOT FULLY SEAT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALUMINA C-TAPER HEAD 32MM/0 IMPLANT LZO STRYKER ORTHOPAEDICS CORK STRYKER ORTHOPAEDICS NA 96819

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other