BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V40 FEM HEAD ORTHINOX 28-0

    MDR report key: 3778491 · Received April 29, 2014

    Report

    Report Number
    0002249697-2014-01549
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    July 1, 2013
    Report Date
    April 4, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K011623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) CENTIMETERS IN HEIGHT. AN EVENT REGARDING SEATING/LOCKING ISSUES WITH A V40 ORTHINOX HEAD WAS REPORTED. THE EVENT WAS NOT CONFIRMED. VISUAL INSPECTION REVEALED THERE ARE SCRATCHES ON TWO SITES ON THE EXTERNAL FACE OF THE HEAD WHICH WOULD HAVE BEEN DONE DURING THE EXPLANTATION OF THE DEVICE. THE DEVICE ANALYSIS CONCLUDED THAT THE DEVICE WAS WITH SPECIFICATION. DEVICE HISTORY REVIEW INDICATED ALL 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. THIS EVENT WAS REPORTED FOR V40 FEM HEAD COULD NOT MATCH UP WITH HFX STEM. THE DEVICE WAS RETURNED AND WAS EVALUATED AND FOUND TO BE WITHIN SPECIFICATION. IT WAS ALSO NOTED DURING THE LABELLING REVIEW FOR THIS DEVICE, THAT THE DEVICE IS SUITABLE FOR USE WITH STAINLESS STEEL STEMS ONLY. THE ACCOLADE HFX CEMENTLESS HIP STEM IS A FORGED COBALT CHROME ALLOY AND IS THEREFORE NOT INDICATED FOR USE WITH THE V40 ORTHINOX HEAD.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE V40 FEM HEAD COULD NOT MATCH UP WITH HFX STEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE V40 FEM HEAD COULD NOT MATCH UP WITH HFX STEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258025 V40 FEM HEAD ORTHINOX 28-0 IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH G31288050

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other