BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER FEMORAL HEAD 28MM DIA. STANDARD NECK

    MDR report key: 1629311 · Received February 5, 2010

    Report

    Report Number
    9610669-2009-00065
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    December 12, 2007
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CAEN, BENOIST GIRARD & CIA 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 EXPIRED PRODUCT) AND PRODUCT CODE (JDI).

    Description of Event or Problem · 1

    IMPLANTED EXPIRED PRODUCT. THE CUSTOMER REPORTED VIA THE SALES REP THAT AS NO OTHER NON-V40 HEADS WERE AVAILABLE AT THE TIME OF SURGERY IN (B) (6) 2007, THE SURGEON IMPLANTED A HEAD THAT HAD EXPIRED IN (B) (6) 2007. THE CUSTOMER FURTHER REPORTED THAT THE PACKAGING WAS INTACT AND NO OTHER OBSERVATIONS WERE NOTED AT THE TIME OF SURGERY. THE CUSTOMER HAS REQUESTED A RISK ASSESSMENT FROM STRYKER AS TO THE POSSIBLE EFFECTS FROM IMPLANTING A PRODUCT THAT WAS 9 MONTHS PAST ITS EXPIRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXETER FEMORAL HEAD 28MM DIA. STANDARD NECK IMPLANT JDI STRYKER ORTHOPAEDICS CAEN, BENOIST GIRARD & CIA S.C.A. NA GA635272

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other