BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON #3 PS ALLPOLY 16MM

    MDR report key: 5769808 · Received July 5, 2016

    Report

    Report Number
    0002249697-2016-02184
    Event Type
    Injury
    Date Received
    July 5, 2016
    Date of Event
    July 23, 2014
    Report Date
    June 9, 2016
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K141056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: TRIATHLON PS FEM COMPONENT, CEMENTED; CAT# 5515-F-401; LOT# KJFKA. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A TRIATHLON FEMORAL COMPONENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS ITEMS WERE NOT RETURNED. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS MEDICAL RECORDS WERE NOT RECEIVED. -DEVICE HISTORY REVIEW: DHR REVIEW FOR THE REPORTED LOT DETERMINED THAT THE DEVICE WAS MANUFACTURED AND PACKED TO SPECIFICATION. -COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW CONFIRMED THAT THERE HAS BEEN NO OTHER SIMILAR EVENT FOR THE REPORTED LOT AND STERILE LOT. CONCLUSIONS: REVISION SURGERY TOOK PLACE DUE TO INFECTION WHEREBY THE REPORTED DEVICES WERE EXPLANTED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED AS INSUFFICIENT INFORMATION WAS PROVIDED FOR THIS INVESTIGATION. FURTHER INFORMATION SUCH AS MEDICAL RECORDS, X-RAYS, OPERATIVE REPORTS AND PATHOLOGY REPORTS DETAILING THE REPORTED INFECTION ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING A ROOT CAUSE. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INFECTION IS A KNOWN POSSIBLE ADVERSE OUTCOME OF SURGERY AND IS BEYOND STRYKER'S CONTROL. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 1

    PATIENT HAD AN INDEX SURGERY OUTSIDE THE RI, PRIOR TO CORS. IN (B)(6) 2014 DR. (B)(6) REVISED THE PATIENT FOR PJI, CHANGED THE FEMUR AND THE POLY. THIS REVISION IS FOR PJI ALL COMPONENTS WERE REMOVED.

    Description of Event or Problem · 1

    PATIENT HAD AN INDEX SURGERY OUTSIDE THE RI, PRIOR TO CORS. IN (B)(6) 2014 DR. (B)(6) REVISED THE PATIENT FOR PJI, CHANGED THE FEMUR AND THE POLY. THIS REVISION IS FOR PJI ALL COMPONENTS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422539 TRIATHLON #3 PS ALLPOLY 16MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH 225959

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention