BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER V40 STEM 44MM NO 0

    MDR report key: 3191716 · Received June 26, 2013

    Report

    Report Number
    0002249697-2013-02085
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K011623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING STEM LENGTH DISCREPANCY INVOLVING AN EXETER V40 STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE VISUAL INSPECTION SHOWS THAT THE STEM LOT NUMBER G2046604 (EXPLANTED EXETER STEM) IS SHORTER THAN THE STEM LOT NUMBER G3654148 (NEW EXETER STEM, NOT IMPLANTED). DIMENSIONAL INSPECTION OF THE STEM LENGTH WAS PERFORMED ON THE NEW STEM LOT NUMBER G3654148 (NOT IMPLANTED) WITH THE GAGE USED IN PRODUCTION AND ALSO WITH A PROFILE GAGE IN ORDER TO HAVE THE EXACT LENGTH. THE CONCLUSION IS THAT THE STEM REPORTED TO BE LONGER BY THE SURGEON (I.E. LOT # G3654148) IS COMPLIANT, HOWEVER THE STEM LENGTH OF THE EXPLANTED DEVICE (LOT # G2046604) IS 2MM SHORTER THAN SPECIFICATION. DEVICE HISTORY RECORDS FOR THE SPECIFIC LOT INDICATED THAT THE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. A REVIEW OF THE COMPLAINT HISTORY DATABASE SHOWS THAT THERE HAVE BEEN NO SIMILAR REPORTED EVENTS FOR THE SUBJECT LOT CODE. THE INVESTIGATION CONCLUDED THAT THE NEW EXETER STEM (NOT IMPLANTED) WAS DIMENSIONALLY COMPLIANT. HOWEVER REGARDING THE EXETER STEM LENGTH DISCREPANCY OF THE EXPLANTED STEM (LOT # G2046604), NC WAS RAISED AND NCR WAS RAISED TO ADDRESS THIS ISSUE. CAPA WAS RAISED TO ADDRESS ROOT CAUSE AND CORRECTIVE ACTION FOR THIS REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    SURGEON REMOVED 44 ZERO EXETER STEM, IMPLANTED SIX YEARS AGO TO ALLOW ACCESS TO REVISING ACETABULUM. TRUNNION DAMAGED OCCURRED SO IMPLANTED A NEW 44 ZERO STEM. THE STEM HUNG UP DESPITE ORIGINAL STEM SLIDING IN WITH NO EFFORT. UPON EXAMINATION THE SURGEON FOUND THE NEW EXETER STEM TO BE LONGER THAN THE EXPLANTED STEM.

    Description of Event or Problem · 1

    SURGEON REMOVED 44 ZERO EXETER STEM, IMPLANTED SIX YEARS AGO TO ALLOW ACCESS TO REVISING ACETABULUM. TRUNNION DAMAGED OCCURRED SO IMPLANTED A NEW 44 ZERO STEM. THE STEM HUNG UP DESPITE ORIGINAL STEM SLIDING IN WITH NO EFFORT. UPON EXAMINATION THE SURGEON FOUND THE NEW EXETER STEM TO BE LONGER THAN THE EXPLANTED STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291757 EXETER V40 STEM 44MM NO 0 IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH G3654148

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other