BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER V40 STEM 35.5MM

    MDR report key: 1629309 · Received February 5, 2010

    Report

    Report Number
    9610669-2009-00064
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    October 26, 2007
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CAEN, BENOIST GIRARD & CIE S.C.A.
    Product Code
    KWY
    PMA / PMN Number
    K011623
    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 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. THE CUSTOMER REPORTED VIA THE KITS DEPARTMENT THAT THE STEM INTRODUCER DID NOT OPERATE. IT IS FURTHER REPORTED THAT AN ALTERNATIVE STEM WAS OPENED AND THE INTRODUCER FROM THAT PACK USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE EFFECTS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXETER V40 STEM 35.5MM IMPLANT KWY STRYKER ORTHOPAEDICS CAEN, BENOIST GIRARD & CIE S.C.A. NA G1282756

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other