BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT PSL HA CLUSTER 54MM

    MDR report key: 4233355 · Received November 6, 2014

    Report

    Report Number
    0002249697-2014-04208
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K983382
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(6). AN EVENT REGARDING LOOSENING INVOLVING A TRIDENT SHELL WAS REPORTED. THE EVENT WAS NOT CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: INSUFFICIENT INFORMATION WAS RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. 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. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION, INCLUDING RETURN OF DEVICE, OPERATIVE REPORTS, X-RAYS, PATIENT HISTORY, PROGRESS NOTES IS NEEDED TO FULLY INVESTIGATE THE EVENT.

    Description of Event or Problem · 1

    CUP REMOVED AND TRITANIUM PRIMARY CUP PUT IN PLACE DUE TO LOOSENING ON PATIENT'S LEFT HIP.

    Description of Event or Problem · 1

    CUP REMOVED AND TRITANIUM PRIMARY CUP PUT IN PLACE DUE TO LOOSENING ON PATIENT'S LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712949 TRIDENT PSL HA CLUSTER 54MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH MMRWMA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R