BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EX V40 POLY TRUNNION PROTECTOR

    MDR report key: 6096113 · Received November 11, 2016

    Report

    Report Number
    0002249697-2016-03568
    Event Type
    Malfunction
    Date Received
    November 11, 2016
    Date of Event
    October 19, 2016
    Report Date
    October 19, 2016
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K153345
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THERE WAS NOT GOOD CONNECTION BETWEEN A COUPLE OF PROTECTORS (EXE-SPIGOT-V40) AND INSERTER. THE PROCEDURE WAS COMPLETED WITHOUT THE PROTECTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748276 EX V40 POLY TRUNNION PROTECTOR PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other