BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT HEMISPHERICAL CLUSTER 52MM

    MDR report key: 3023784 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01104
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K013676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE LIMITED INFORMATION PROVIDED. FURTHER INFORMATION SUCH AS RETURN OF THE EXPLANTED DEVICES FOR ANALYSIS, PRE- AND POST-OPERATIVE XRAYS, OPERATIVE REPORTS, PATIENT HISTORY & FOLLOW UP NOTES ARE NEEDED TO CONFIRM THE REPORTED EVENT AND DETERMINE THE ROOT CAUSE.

    Description of Event or Problem · 1

    LOOSE CUP WAS REMOVED AND NEW CUP IMPLANTED.

    Description of Event or Problem · 1

    LOOSE CUP WAS REMOVED AND NEW CUP IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126152 TRIDENT HEMISPHERICAL CLUSTER 52MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 24801801

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| O| R