BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER V40 STEM 37.5MM NO 1

    MDR report key: 1905663 · Received November 12, 2010

    Report

    Report Number
    9616680-2010-00724
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 28, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JDI
    PMA / PMN Number
    K891454
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE NURSE THAT WHEN THEY OPENED THE PACKAGE, THE CENTRALIZER WAS MISSING. THEY USED A CENTRALIZER FROM ANOTHER PACKAGE INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXETER V40 STEM 37.5MM NO 1 IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA G3000302

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other