BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM

    MDR report key: 2850368 · Received November 16, 2012

    Report

    Report Number
    2249697-2012-02371
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 31, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K081171
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED, BUT NOT MADE AVAILABLE. WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, PATIENT HAD LOOSENING OF THE CUP, IT WAS CAUSING PAIN. DR (B)(6) WAS NOT THE ORIGINAL SURGEON AS THE IMPLANT WAS DONE OUT OF STATE. HE PULLED THE STEM SINCE IT WAS RECALLED, AND REPLACED IT WITH A ZIMMER HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM IMPLANT LPH STRYKER ORTHOPAEDICS MAHWAH NA MHDV5J

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention