BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PS X3 TIBIAL INSERT

    MDR report key: 3023981 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01132
    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
    K051146
    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 (B)(6). MEDICAL RECORDS AND X-RAYS WERE NOT PROVIDED TO STRYKER FOR REVIEW DUE TO IRB RESTRICTIONS AT REPORTER'S INSTITUTION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING INSTABILITY INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: A PHOTOGRAPH OF THE DEVICE WAS PROVIDED. THE COMPONENT APPEARED CONSISTENT WITH A DEVICE THAT HAD BEEN IN VIVO AND WAS SUBSEQUENTLY REMOVED. THE INSERT COMPONENT HAD EXPLANTATION DAMAGE EVIDENT. MEDICAL RECORDS RECEIVED AND EVALUATION: MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY REVIEW: THERE HAVE BEEN NO REPORTED RELEVANT DISCREPANCIES FOR THE REFERENCED LOT. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO REPORTED SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE REPORTED EVENT CANNOT BE CONFIRMED WITH THE INFORMATION PROVIDED. FURTHER INFORMATION SUCH AS MEDICAL RECORDS, X-RAYS, PATIENT DETAILS AND CLINICAL HISTORY ARE REQUIRED TO INVESTIGATE THIS EVENT. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INSTABILITY MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE.

    Description of Event or Problem · 1

    THE ARTHOPLASTY WAS REVISED DUE TO INSTABILITY AND RECURRENT EFFUSIONS. THE COMPONENTS WERE IMPLANTED IN SITU FOR ~1.0 Y. THE TIBIAL POLYETHYLENE TIBIAL INSERT WAS REVISED. THE PATIENT PRESENTED WITH A UCLA SCORE OF 3 THREE MONTHS PRIOR TO REVISION SURGERY AND A MAXIMUM SCORE OF 3.

    Description of Event or Problem · 1

    THE ARTHROPLASTY WAS REVISED DUE TO INSTABILITY AND RECURRENT EFFUSIONS. THE COMPONENTS WERE IMPLANTED IN SITU FOR APPROX 1.0 Y. THE TIBIAL POLYETHYLENE TIBIAL INSERT WAS REVISED. THE PATIENT PRESENTED WITH A UCLA SCORE OF 3 THREE MONTHS PRIOR TO REVISION SURGERY AND A MAXIMUM SCORE OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126258 TRIATHLON PS X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MHT0H1

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention