BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT ALUMINA INSERT

    MDR report key: 2941851 · Received February 4, 2013

    Report

    Report Number
    0002249697-2013-00535
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MRA
    PMA / PMN Number
    P000013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 6565-0-232, LOT # UNK, DESCRIPTION: ALUMINA V40-FEMORAL HEAD 32MM, +4MM NK. CAT # 6020-0335, LOT # UNK, DESCRIPTION: ACCOLADE TMZF HIP STEM #3. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    WHILE THE EXACT ROOT CAUSE OF THE ALLEGED NOISE AND PAIN COULD NOT BE DETERMINED, IN THE EVENT DESCRIPTION, IT STATED THAT THE SURGEON REVISED PATIENT DUE TO PAIN AND CLICKING IN HIP. FURTHER INFORMATION SUCH AS DEVICE RETURN, OPERATIVE REPORTS, XRAYS, PATIENT HISTORY & FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR CONFIRMING THE EVENT AND DETERMINING THE ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RIGHT HIP WAS REVISED. SURGEON REVISED PATIENT DUE TO PAIN AND CLICKING IN HIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RIGHT HIP WAS REVISED. SURGEON REVISED PATIENT DUE TO PAIN AND CLICKING IN HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46941 TRIDENT ALUMINA INSERT IMPLANT MRA STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| O| R