BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 60MM

    MDR report key: 2871889 · Received December 6, 2012

    Report

    Report Number
    2249697-2012-02588
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LPH
    PMA / PMN Number
    K081171
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REJUVENATE STEM AND NECK WERE EXTRACTED. THE CUP WAS LOOSE AND EXTRACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 60MM IMPLANT LPH STRYKER ORTHOPAEDICS CORK NA MJK534

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention