BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EIUS UNI TIB MED 8MM LM/RL

    MDR report key: 1679098 · Received May 2, 2010

    Report

    Report Number
    9610726-2009-00292
    Event Type
    Malfunction
    Date Received
    May 2, 2010
    Date of Event
    January 4, 2007
    Report Date
    January 4, 2007
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    HSX
    PMA / PMN Number
    K992287
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN STRYKER CORP 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 ARE PART OF A RETROSPECTIVE SUMMARY REPORT BEING SUBMITTED UNDER EXEMPTION # (B) (4). THERE IS 1 EVENT ASSOCIATED WITH THIS EVENT TYPE (DEVICE DID NOT FUNCTION AS EXPECTED) AND PRODUCT CODE HSX. METHOD: DHR AND COMPLAINT HISTORY REVIEW.

    Description of Event or Problem · 1

    (B) (4) - DEVICE DID NOT FUNCTION AS EXPECTED. IT WAS REPORTED THAT THERE REMAINS SOME MOVEMENT BETWEEN THE PROSTHESIS AND THE CEMENT MANTLE. EVEN THOUGH THE TRIAL IMPLANTS ARE VERY STABLE AND NOT MOVING IN DEEP FLEXION, A CEMENTED PROTHESIS ALWAYS TILTS UP ANTERIORLY IN FLEXION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EIUS UNI TIB MED 8MM LM/RL IMPLANT HSX STRYKER ORTHOPAEDICS NA LAC977

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR