BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X3 TRIATHLON CS INS SIZE 4 9MM

    MDR report key: 3940735 · Received July 17, 2014

    Report

    Report Number
    0002249697-2014-02755
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    March 27, 2013
    Report Date
    June 27, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K063423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(6). AN EVENT REGARDING PAIN INVOLVING A TRIATHLON KNEE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE DEVICE REMAINS IMPLANTED. -MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED, ¿OTHER THAN THE AUGUST 6, 2014 ADDENDUM TO THIS REPORT AT REQUEST OF THE PATIENT, NO CONFIRMATION OF THE COMPLAINTS NOTED IN THE EVENT DESCRIPTION ARE AVAILABLE. THERE IS NO EVIDENCE OF THE RIGHT ARTHROSCOPY HAVING BEEN PERFORMED. THE OPERATIVE REPORT OF THE BILATERAL TOTAL KNEE ARTHROPLASTY SURGERIES DOES NOT INDICATE ANY RECALLED GUIDES USED DURING THE SURGERIES. THERE IS NO EVIDENCE THAT FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS ARE RESPONSIBLE FOR THIS PATIENT¿S CLINICAL COMPLAINTS.¿ -DEVICE HISTORY REVIEW: ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATION. THE DEVICES WERE NOT SUBJECT TO A RECALL. -COMPLAINT HISTORY REVIEW: NOT PERFORMED BECAUSE NO DEVICE SPECIFIC FAILURE MODE WAS IDENTIFIED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE THERE WAS NO CONFIRMATION IN THE MEDICAL RECORDS OF THE COMPLAINTS NOTED IN THE EVENT DESCRIPTION. THE FOLLOWING PRODUCT WAS ADDED TO THE COMPLAINT AFTER THE INITIAL MEDWATCH WAS SUBMITTED: CAT. NO.: 5510-F-401, TRIATHLON CR FEM COMP #4 L-CEM, LOT CODE: EAJ9M. CAT. NO.: 5520-B-400, TRIATHLON PRIM TIB BASEPLATE - CEMENTED, LOT CODE: GOASA. CAT. NO.: 5551-G-299, TRIATHLON ASYMMETRIC X3 PATELLA, LOT CODE: 4DMM. CAT. NO.: 6197-9-001, SIMPLEX P WITH TOBRAMYCIN 1 PACK, LOT CODE: MBU020.

    Description of Event or Problem · 1

    PATIENT REPORTS PAIN. PATIENT REPORTS EXCESSIVE BLEEDING DURING SURGERY. PAIN FEELS LIKE TWO PIPES GRINDING TOGETHER PINCHING A NERVE. PATIENT ICES KNEES EVERYDAY AND PHYSICAL THERAPY DOES NOT HELP. PATIENT SAYS IT FEELS LIKE THERE IS GRAVEL UNDER HER KNEE CAPS.

    Description of Event or Problem · 1

    PATIENT REPORTS PAIN. PATIENT REPORTS EXCESSIVE BLEEDING DURING SURGERY. PAIN FEELS LIKE TWO PIPES GRINDING TOGETHER PINCHING A NERVE. PATIENT ICES KNEES EVERYDAY AND PHYSICAL THERAPY DOES NOT HELP. PATIENT SAYS IT FEELS LIKE THERE IS GRAVEL UNDER HER KNEE CAPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418257 X3 TRIATHLON CS INS SIZE 4 9MM IMPLANT MBH STRYKER ORTHOPAEDICS-MAHWAH LDA293

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other