BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 4123258 · Received September 26, 2014

    Report

    Report Number
    0002249697-2014-03648
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE SALES REP INFORMED THE DEVICE WAS NOT RELEASED BY THE HOSPITAL. AN EVENT REGARDING REVISION DUE TO LOOSENING INVOLVING AN AN UNKNOWN TIBIA WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE PROVIDED MEDICAL INFORMATION WAS SUBMITTED TO A CONSULTING CLINICIAN WHO DEEMED IT INSUFFICIENT FOR A MEDICAL REVIEW. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. CONCLUSIONS: THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED. IF THE DEVICES AND/OR ADDITIONAL INFORMATION ARE RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD BEEN COMPLAINING OF PAIN. REVISED TRIATHLON TS DUE TO TIBIAL/FEMORAL LOOSENING. PATELLA STAYED IN PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD BEEN COMPLAINING OF PAIN. REVISED TRIATHLON TS DUE TO TIBIAL/FEMORAL LOOSENING. PATELLA STAYED IN PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602475 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention