BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER FEMORAL HEAD 28M DIA STANDARD NECK

    MDR report key: 1629307 · Received February 5, 2010

    Report

    Report Number
    9610669-2009-00061
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    March 16, 2008
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CAEN, BENOIST GIRARD & CIE S.C.A.
    Product Code
    JDI
    PMA / PMN Number
    K891454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 ARE PART OF A RETROSPECTIVE SUMMARY REPORT BEING SUBMITTED UNDER EXEMPTION (B) (4). THERE IS 1 EVENT ASSOCIATED WITH THIS EVENT TYPE (USER RELATED - IMPLANTED INCOMPATIBLE DEVICES) AND PRODUCT CODE (JDI).

    Description of Event or Problem · 1

    USER RELATED - IMPLANTED INCOMPATIBLE DEVICES. THE CUSTOMER REPORTED VIA THE SALES REP THAT THE PT WAS IMPLANTED WITH AN EXETER V40 BIPOLAR AND A NON V40 HEAD. THE CUSTOMER STATES THE PT WAS TOLD AND WAS DISCHARGED WITHOUT REVISING THE HEAD, AND WILL BE MONITORED BY THE SURGEON. THE CUSTOMER HAS REQUESTED VIA THE SALES REP FOR CLARIFICATION ON THE LABEL TO STATE IT IS A NON V40 HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXETER FEMORAL HEAD 28M DIA STANDARD NECK IMPLANT JDI STRYKER ORTHOPAEDICS CAEN, BENOIST GIRARD & CIE S.C.A. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA