BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM

    MDR report key: 3782079 · Received April 30, 2014

    Report

    Report Number
    0002249697-2014-01649
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    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

    OTHER DEVICES LISTED IN THIS REPORT: CAT. NO.: 5521-B-600 TRI TS BASEPLATE SIZE 6, LOT CODE: GTVX , CAT. NO.: UNKNOWN, FEMORAL CONDYLE, LOT CODE: UNKNOWN. AT THIS TIME, IT CANNOT BE DETERMINED IF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. VISUAL INSPECTION: PHOTOS OF THE REPORTED DEVICE INDICATES THERE IS SOME WEAR AND DISCOLORATION CONSISTENT WITH IN VIVO USE. NOTHING MORE CAN BE LEARNED FROM THE PROVIDED PHOTOS. DIMENSIONAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. THE PROVIDED RECORDS WERE SUBMITTED TO CLINICIAN AND DEEMED INSUFFICIENT FOR MEDICAL REVIEW. PATHOLOGY REPORTS, MICRO REPORTS AND PRIMARY OPERATIVE REPORTS. ARE NEEDED TO COMPLETE REVIEW. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INFECTION IS MOST LIKELY A RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE IN THE HEALTHCARE FACILITY SETTING. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    THE ARTHROPLASTY WAS REVISED DUE TO INFECTION & EXTENSOR MECHANISM RUPTURE . THE COMPONENTS WERE IMPLANTED IN SITU FOR ~ 0.01 Y. THE TIBIAL AND FEMORAL COMPONENTS WERE REVISED.

    Description of Event or Problem · 1

    THE ARTHROPLASTY WAS REVISED DUE TO INFECTION & EXTENSOR MECHANISM RUPTURE . THE COMPONENTS WERE IMPLANTED IN SITU FOR ~ 0.01 Y. THE TIBIAL AND FEMORAL COMPONENTS WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260933 NO 6. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 16MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH MLANTE

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention