BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCR,RCI,9X25 STER

    MDR report key: 432179 · Received November 8, 2002

    Report

    Report Number
    1219602-2002-00189
    Event Type
    Other
    Date Received
    November 8, 2002
    Date of Event
    November 13, 2000
    Report Date
    October 7, 2002
    Manufacturer
    SMITH & NEPHEW INC. ENDOSCOPY DIVIS
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT ACL RECONSTRUCTION OF THEIR RIGHT KNEE AT A FACILITY. THEY APPEARED TO DO VERY WELL THEREAFTER AND REHABBED TO A GOOD LEVEL OF ACTIVITY. AFTER THIS HOWEVER, THEIR RIGHT KNEE STARTED TO GIVE THEM PROBLEMS WITH RECURRENT EFFUSIONS. THE MEDICAL FACILITY RE-ARTHROSCOPED THEM AND FOUND A LATERAL MENISCAL TEAR WHICH WAS RESECTED AND SYNOVITIS OF THE RIGHT KNEE WAS NOTED. MULTIPLE BIOPSIES WERE TAKEN SUGGESTING AN INFLAMMATORY ARTHROPATHY AND THEY HAVE BEEN UNDER THE CARE OF THE RHEUMATOLOGIST WHO DIAGNOSED THEM AS HAVING A POLYARTHRITIS OF UNSPECIFIED NATURE. THE PATIENT IS CONVINCED THAT THE RCI SCREWS ARE THE ROOT CAUSE OF THEIR UNSPECIFIED INFLAMMATORY ARTHROPATHY WHICH IS NOW AFFECTING BOTH KNEES AND BOTH ANKLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCR,RCI,9X25 STER * HWC SMITH & NEPHEW INC. ENDOSCOPY DIVIS 7207301 441851

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other