BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    32MM -4MM V40 TRIAL HEAD

    MDR report key: 6171684 · Received December 13, 2016

    Report

    Report Number
    0002249697-2016-03902
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    October 28, 2016
    Report Date
    November 1, 2016
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K153345
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    TRIAL HEADS LOOSEN OFF FROM THE RASP AND STEM. DURING LUXATION AFTER TRIAL REDUCTION THE TRIAL HEAD COMES LOOSE FROM THE RASP/STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822368 32MM -4MM V40 TRIAL HEAD PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other