BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON CS INSERT #5 9MM

    MDR report key: 4880571 · Received June 30, 2015

    Report

    Report Number
    0002249697-2015-02168
    Event Type
    Injury
    Date Received
    June 30, 2015
    Date of Event
    February 10, 2015
    Report Date
    June 9, 2015
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING REVISION OF A TRIATHLON INSERT FOR UNSPECIFIED REASON WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS NO ITEMS WERE RETURNED. -MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS NO MEDICAL RECORDS WERE PROVIDED. -DEVICE HISTORY REVIEW: DHR REVIEW FOR THIS LOT WAS SATISFACTORY. -COMPLAINT HISTORY REVIEW: INDICATED THAT THERE HAVE BEEN NO OTHER SIMILAR REPORTED EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS 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. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICES WERE ALSO LISTED IN THIS REPORT: TRIATHLON CR FEM COMP #6 R-CEM; CAT# 5510-F-602; LOT# EHMTM. TRIATHLON PRIM CEM FXD BPLT #5; CAT# 5520-B-500; LOT# EKDXD. TRIATHLON ASYMMETRIC X3 PATELLA; CAT# 5551-G-320; LOT# 7K1P. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT PROVIDED. 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

    TOTAL KNEE REVISION. I&D AND EXCHANGE OF POLY COMPONENT.

    Description of Event or Problem · 1

    TOTAL KNEE REVISION. I&D AND EXCHANGE OF POLY COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422166 X3 TRIATHLON CS INSERT #5 9MM IMPLANT MBH STRYKER ORTHOPAEDICS-MAHWAH LEA512

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention