BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY TRITANIUM HEMI SOLIDBACK CUP 54MM

    MDR report key: 6901507 · Received September 28, 2017

    Report

    Report Number
    0002249697-2017-02872
    Event Type
    Malfunction
    Date Received
    September 28, 2017
    Date of Event
    August 30, 2017
    Report Date
    December 8, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    UDI-DI
    07613327040012
    PMA / PMN Number
    K081171
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A PACKAGING ISSUE INVOLVING A TRITANIUM SHELL WAS REPORTED. THE EVENT WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    THE PRODUCT WAS PACKAGED OFF CENTER IN THE PLASTIC TUB AND THE ROUGH SURFACE OF THE SHELL RUBBED AGAINST THE PLASTIC. IT CREATED PLASTIC PARTICLES IN THE SHELL.

    Description of Event or Problem · 1

    THE PRODUCT WAS PACKAGED OFF CENTER IN THE PLASTIC TUB AND THE ROUGH SURFACE OF THE SHELL RUBBED AGAINST THE PLASTIC. IT CREATED PLASTIC PARTICLES IN THE SHELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682750 PRIMARY TRITANIUM HEMI SOLIDBACK CUP 54MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH A86X7H 07613327040012

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other