BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM

    MDR report key: 3961956 · Received July 28, 2014

    Report

    Report Number
    0002249697-2014-02883
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K081171
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING MALPOSITION INVOLVING A TRITANIUM SHELL WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION COULD NOT BE PERFORMED AS THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS RECEIVED AND EVALUATION. A MEDICAL REVIEW WAS NOT PERFORMED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO ILIOPSOAS TENDON IMPINGEMENT. MALPOSITION OF THE CUP MAY EXPOSE ANTERIOR CUP RIM TO PSOAS TENDON THAT CAN LEAD TO PSOAS PAIN, HOWEVER THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A REVISION OF RIGHT HIP DUE TO ILIOPSOAS TENDON IMPINGEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A REVISION OF RIGHT HIP DUE TO ILIOPSOAS TENDON IMPINGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437997 PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MMKP87

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention