BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON CS INSERT #5 9MM

    MDR report key: 3885071 · Received June 19, 2014

    Report

    Report Number
    0002249697-2014-02379
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 7, 2012
    Report Date
    May 30, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K063423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN RIGHT STRYKER KNEE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING PAIN, REDUCED RANGE OF MOTION, AND POPPING/GRINDING INVOLVING A TRIATHLON INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED, ¿THERE IS NO DOCUMENTED CONFIRMATION OF THE COMPLAINTS NOTED IN THE EVENT DESCRIPTION. THERE IS NO EVIDENCE OF FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS BEING RESPONSIBLE FOR THIS CLINICAL SITUATION. ¿ DEVICE HISTORY REVIEW: ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATION. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE THERE IS NO DOCUMENTED CONFIRMATION OF THE COMPLAINTS IN THE MEDICAL RECORDS PROVIDED. WHILE THE CLINICAL ROOT CAUSE CANNOT BE DETERMINED, THE CLINICAL CONSULTANT INDICATED THERE IS NO EVIDENCE OF FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS BEING RESPONSIBLE FOR THIS CLINICAL SITUATION. THE FOLLOWING ADDITIONAL PRODUCT WAS ADDED TO THE COMPLAINT AFTER THE INITIAL MEDWATCH WAS SUBMITTED. CAT. NO.: 5510-F-402, TRIATHLON CR FEM COMP #4 R-CEM, LOT CODE: S7D6T. CAT. NO.: 5520-B-500, TRIATHLON PRIM CEM FXD BPLT #5, LOT CODE: S83FM. CAT. NO.: 5551-G-320, TRIATHLON ASYMMETRIC X3 PATELLA, LOT CODE: 7V5R.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DAY AFTER PATIENTS' SURGERY; SHE FELL AND DEVELOPED A BLOOD CLOT IN LEG. PATIENT IS NOW IN CONSTANT PAIN, LEG LOCKS UP; SHE HEARS POPPING AND GRINDING SOUND IN KNEE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DAY AFTER PATIENTS' SURGERY; SHE FELL AND DEVELOPED A BLOOD CLOT IN LEG. PATIENT IS NOW IN CONSTANT PAIN, LEG LOCKS UP; SHE HEARS POPPING AND GRINDING SOUND IN KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361212 X3 TRIATHLON CS INSERT #5 9MM IMPLANT MBH STRYKER ORTHOPAEDICS-MAHWAH LCR102

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention