BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY TRITANIUM HEMI SOLIDBACK CUP 50MM

    MDR report key: 3102766 · Received May 9, 2013

    Report

    Report Number
    0002249697-2013-01588
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 26, 2013
    Report Date
    February 16, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K081171
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    REVISION TOTAL HIP FOR ACETABULAR LOOSENING. STEM WAS ALSO REMOVED BY SURGEON AS PRECAUTIONARY MEASURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204347 PRIMARY TRITANIUM HEMI SOLIDBACK CUP 50MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH MJND6L

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention