BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM

    MDR report key: 3120742 · Received May 20, 2013

    Report

    Report Number
    0002249697-2013-01727
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 27, 2013
    Report Date
    April 27, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K081171
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE HOSPITAL AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND NO MEDICAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENTED TO OFFICE WITH PAINFUL HIP. X-RAY REVEALED MALPOSITIONED CUP, TAKEN TO OR AND REVISED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENTED TO OFFICE WITH PAINFUL HIP. X-RAY REVEALED MALPOSITIONED CUP, TAKEN TO OR AND REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221864 PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 54MM IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MKJYPY

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention