BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON CR FEM COMP #4 R-CEM

    MDR report key: 3083234 · Received April 29, 2013

    Report

    Report Number
    0002249697-2013-01478
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K040267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6). UPDATED DEVICE MANUFACTURE DATE BASED ON ADDITIONAL INFORMATION. AN EVENT REGARDING LOOSENING INVOLVING A TRIATHLON FEMORAL COMPONENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. IMAGES OF THE EXPLANTED DEVICES WERE PROVIDED. A VIEW OF THE FEMORAL COMPONENT CONDYLES DID NOT PROVIDE ANYTHING OF NOTE THE INVESTIGATION. FURTHER INSPECTIONS WERE NOT PERFORMED AS THE RESEARCH FACILITY RETAINED THE EXPLANTED DEVICES. DEVICE HISTORY REVIEW INDICATED THERE HAVE BEEN NO REPORTED DISCREPANCIES FOR THE REFERENCED LOT. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO REPORTED EVENTS FOR THE LOT REFERENCED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION SUCH AS PRE- AND POST-OPERATIVE X-RAYS AND THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. MEDICAL RECORDS AND X-RAYS WERE NOT PROVIDED TO STRYKER FOR REVIEW DUE TO IRB RESTRICTIONS AT REPORTERS INSTITUTION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED .

    Description of Event or Problem · 1

    THE ARTHROPLASTY WAS REVISED DUE TO FEMORAL LOOSENING, TIBIAL LOOSENING, AND PATELLA LOOSENING. THE COMPONENTS WERE IMPLANTED IN SITU FOR ~1.8 Y . THE TIBIAL INSERT, TIBIAL TRAY, FEMORAL AND PATELLA WERE REVISED. THE PATIENT PRESENTED WITH A UCLA SCORE OF 2 THREE MONTHS PRIOR TO REVISION SURGERY AND A MAXIMUM SCORE OF 3.

    Description of Event or Problem · 1

    THE ARTHROPLASTY WAS REVISED DUE TO FEMORAL LOOSENING, TIBIAL LOOSENING, AND PATELLA LOOSENING. THE COMPONENTS WERE IMPLANTED IN SITU FOR APPROX 1.8 Y. THE TIBIAL INSERT, TIBIAL TRAY, FEMORAL AND PATELLA WERE REVISED. THE PATIENT PRESENTED WITH A UCLA SCORE OF 2 THREE MONTHS PRIOR TO REVISION SURGERY AND A MAXIMUM SCORE OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183789 TRIATHLON CR FEM COMP #4 R-CEM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH STMSN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention