BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNITRAX MODULAR ENDO HEAD 54MM

    MDR report key: 2716265 · Received August 21, 2012

    Report

    Report Number
    2249697-2012-01305
    Event Type
    Malfunction
    Date Received
    August 21, 2012
    Date of Event
    July 22, 2012
    Report Date
    July 31, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWL
    PMA / PMN Number
    K014226
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EXPIRED IMPLANT WAS IMPLANTED. EXP DATE 06/2012. NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNITRAX MODULAR ENDO HEAD 54MM IMPLANT KWL STRYKER ORTHOPAEDICS MAHWAH NA A07K454

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK