BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALUMINA V40-FEMORAL HEAD 36MM, +5MM NK

    MDR report key: 1622643 · Received February 5, 2010

    Report

    Report Number
    9616680-2009-00687
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    September 14, 2007
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK STRYKER ORTHOPAEDICS
    Product Code
    LZO
    PMA / PMN Number
    K023901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 7/1/2006 TO 7/1/2008 WERE THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE PART OF A RETROSPECTIVE SUMMARY REPORT BEING SUBMITTED UNDER EXEMPTION # (B)(4). THERE ARE 2 EVENTS ASSOCIATED WITH THIS EVENT TYPE (DEVICE DID NOT FUNCTION AS EXPECTED AND PRODUCT CODE JDI).

    Description of Event or Problem · 1

    DEVICE DID NOT FUNCTION AS EXPECTED. IT WAS REPORTED: "IT WAS NOTICED AFTER IMPACTION OF THE ITEM THAT IT WAS NOT SEATED ALL THE WAY DOWN AND LOOKED UNUSUALLY PROUD. AFTER SUCCESSFULLY REDUCING THE JOINT, IT CONFIRMED THAT IT WAS TOO LONG. DISLOCATED JOINT AND NOTICED THAT IT WAS CROOKED. CHECKED THE HEAD TRIALS AND STEM TRUNNION FOR DISCREPANCIES. DOCTOR CONFIRMED IT WAS THE HEAD BECAUSE WE TRIMMED NUMEROUS TIMES. HE THEN USED A 10 36MM HEAD WHICH WENT ON FINE AND CLOSED THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALUMINA V40-FEMORAL HEAD 36MM, +5MM NK IMPLANT LZO STRYKER ORTHOPAEDICS CORK STRYKER ORTHOPAEDICS NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other