BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PRIM TIB BASEPLATE - CEMENTED

    MDR report key: 3083262 · Received April 29, 2013

    Report

    Report Number
    0002249697-2013-01477
    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
    K031729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING LOOSENING INVOLVING A TRIATHLON TIBIAL COMPONENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. IMAGES OF THE EXPLANTED DEVICES WERE PROVIDED. A VIEW OF THE TIBIAL COMPONENT DID NOT PROVIDE ANYTHING OF NOTE FOR THE INVESTIGATION. FURTHER INSPECTIONS WERE NOT PERFORMED AS THE RESEARCH FACILITY RETAINED THE EXPLANTED DEVICES. MEDICAL RECORDS EVALUATION NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED. A DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. THERE HAVE BEEN NO REPORTED EVENTS FOR THE LOT REFERENCED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION IS NEEDED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    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.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183919 TRIATHLON PRIM TIB BASEPLATE - CEMENTED IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH BMIH

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention