BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON CS INSERT #6 9MM

    MDR report key: 4054575 · Received September 3, 2014

    Report

    Report Number
    0002249697-2014-03367
    Event Type
    Injury
    Date Received
    September 3, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 14, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K063423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES LISTED IN THIS REPORT: CAT # 5551-G-381, LOT # 2KK8, DESCRIPTION: TRIATHLON ASYMMETRIC X3 PATELLA. CAT # 5520-B-600, LOT # S8YXF, DESCRIPTION: TRIATHLON PRIM TIB BASEPLATE ¿ CEMENTED. CAT # 5510-F-502, LOT # S3TNK, DESCRIPTION: TRIATHLON CR FEM COMP #5 R-CEM. CAT # 8000-0046, LOT # V2011087A, DESCRIPTION: DISPOSABLE PATELLA CUTTER 46MM. CAT # 7650-2038A, LOT # RD7M011E, DESCRIPTION: STERILE FLUTED HEADLESS 1/8" PIN 3.5" LONG. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. HOSPITAL POLICY.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A TRIATHLON CS X3 INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION WAS NOT PERFORMED AS NO ITEMS WERE RETURNED. MEDICAL EVALUATION NOT PERFORMED AS NO MEDICAL RECORDS WERE RECEIVED. 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 OR STERILE LOT REFERENCED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. A 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.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A REVISION OF RIGHT KNEE DUE TO INFECTION. DOCTOR DID A POLY EXCHANGE AND WASHED PATIENT OUT.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT HAD A REVISION OF RIGHT KNEE DUE TO INFECTION. DOCTOR DID A POLY EXCHANGE AND WASHED PATIENT OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539348 X3 TRIATHLON CS INSERT #6 9MM IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH LCV419

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R