BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM

    MDR report key: 3023993 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01137
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    January 1, 2011
    Report Date
    March 8, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K072221
    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. DEVICES WERE RETAINED AT DREXEL IMPLANT RESEARCH CENTER. 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. THE OTHER DEVICE LISTED IN THIS REPORT. AT THIS TIME, IT CANNOT BE DETERMINED IF THIS DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. CAT # UNK LOT # UNK DESCRIPTION: TRIATHLON PRIM CEM FXD BPLT #5. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE CATALOG NUMBER WAS UPDATED BASED ON REVIEW OF DEVICE HISTORY. THE PATIENT IS (B)(6). AN EVENT REGARDING INSTABILITY INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. PROXIMAL AND DISTAL VIEWS OF THE TRIATHLON X3 CS INSERT WERE PROVIDED. THE PROXIMAL VIEW SHOWS THIRD BODY INDENTATIONS ON THE ARTICULATING SURFACES AND BURNISHING OF THE POST. DAMAGE TO THE ANTERIOR LOCKING MECHANISM AND ABRASIONS TO THE ANTERIOR SURFACE FROM THE REMOVAL PROCESS ARE OBSERVED IN THE DISTAL VIEW. FURTHER INSPECTION COULD NOT BE 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 FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE.

    Description of Event or Problem · 1

    THE ARTHROPLASTY WAS REVISED DUE TO INSTABILITY AND PAIN. THE COMPONENTS WERE IMPLANTED IN SITU FOR ~1.5 Y. THE FEMORAL CONDYLES POLYETHYLENE TIBIAL INSERT WERE REVISED.

    Description of Event or Problem · 1

    THE ARTHROPLASTY WAS REVISED DUE TO INSTABILITY AND PAIN. THE COMPONENTS WERE IMPLANTED IN SITU FOR ~1.5 Y. THE FEMORAL CONDYLES POLYETHYLENE TIBIAL INSERT WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126543 NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 13MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MHLJDJ

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention