BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER V40 STEM 50MM NO 2

    MDR report key: 1812921 · Received August 16, 2010

    Report

    Report Number
    9610669-2010-00087
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 16, 2010
    Report Date
    July 22, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CAEN
    Product Code
    JDI
    PMA / PMN Number
    K011623
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. IF ADDITIONAL INFO BECOMES AVAILABLE, THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA THE SALES REP THAT WHEN THE UNIT WAS OPENED BOTH OF THE CENTRALIZERS WERE MISSING. THE SALES REP FURTHER REPORTED THAT OTHER CENTRALIZERS WERE AVAILABLE TO COMPLETE THE SURGERY. THE SALES REP FURTHER REPORTED THAT THERE WAS NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXETER V40 STEM 50MM NO 2 IMPLANT JDI STRYKER ORTHOPAEDICS CAEN NA G2661327

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention