BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON INSERT PS#7 9MM

    MDR report key: 5724149 · Received June 14, 2016

    Report

    Report Number
    0002249697-2016-01958
    Event Type
    Injury
    Date Received
    June 14, 2016
    Date of Event
    May 19, 2016
    Report Date
    May 19, 2016
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K141056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING REVISION SURGERY DUE TO INSTABILITY INVOLVING A TRIATHLON PS INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED. DEVICE HISTORY REVIEW: THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. REVISION SURGERY TOOK PLACE DUE TO INSTABILITY WHEREBY A THICKER INSERT WAS IMPLANTED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS PRODUCT RETURN, PRE- AND POST-OPERATIVE X-RAYS, OPERATIVE REPORTS AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING A ROOT CAUSE. 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. NO FURTHER INVESTIGATION IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS DISPOSED OF BY THE HOSPITAL AND NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    PATIENT PRESENTED IN CLINIC AND WAS LOOSE LATERALLY FOLLOWING LTK REPLACEMENT ON (B)(6) 2016. PATIENT HAD DEVELOPED ACUTE GOUT FOLLOWING HIS PRIMARY LTK. DR. (B)(6) EXCHANGED POLY + NOTED THE POPLITEUS HAD BECOME COMPROMISED MOST LIKELY AT SOME POINT POST OP. DR. (B)(6) REIMPLANTED A 7 X 13 PS INSERT.

    Description of Event or Problem · 1

    PATIENT PRESENTED IN CLINIC AND WAS LOOSE LATERALLY FOLLOWING LTK REPLACEMENT ON (B)(6) 2016. PATIENT HAD DEVELOPED ACUTE GOUT FOLLOWING HIS PRIMARY LTK. DR. (B)(6) EXCHANGED POLY + NOTED THE POPLITEUS HAD BECOME COMPROMISED MOST LIKELY AT SOME POINT POST OP. DR. (B)(6) REIMPLANTED A 7 X 13 PS INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378915 X3 TRIATHLON INSERT PS#7 9MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH LET834

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention