BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON PS X3 TIBIAL INSERT

    MDR report key: 3051295 · Received April 10, 2013

    Report

    Report Number
    0002249697-2013-01243
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) INCHES IN HEIGHT. AN EVENT REGARDING SCAR TISSUE (ARTHROFIBROSIS) INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: THE DEVICE SHOWS LIGHT DAMAGE ON THE BEARING SURFACE CONSISTENT WITH CLINICAL USE AND ALSO EXPLANTATION DAMAGE. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED FOR REVIEW. DEVICE HISTORY REVIEW: THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: BASED ON THE INFORMATION PROVIDED, THE INSERT NEEDED TO BE REMOVED TO GAIN ACCESS TO THE POSTERIOR CAPSULE IN ORDER TO REMOVE SCAR TISSUE. THERE IS NO INDICATION OR ALLEGATION THAT THE INSERT CONTRIBUTED TO THE REPORTED EVENT. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED ARTHROFIBROSIS MAY RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE.

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    POLY INSERT OF A TRIATHLON TOTAL KNEE WAS REMOVED TO GAIN ACCESS TO THE POSTERIOR CAPSULE. ACCESS WAS NEEDED TO REMOVE SCAR TISSUE.

    Description of Event or Problem · 1

    POLY INSERT OF A TRIATHLON TOTAL KNEE WAS REMOVED TO GAIN ACCESS TO THE POSTERIOR CAPSULE. ACCESS WAS NEEDED TO REMOVE SCAR TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153633 TRIATHLON PS X3 TIBIAL INSERT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MLRKVP

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention