BEUDAMED
    FDA Adverse Event Summary report: N

    SIGMA TOTAL KNEE

    MDR report key: 2511273 · Received March 26, 2012

    Report

    Report Number
    MW5024807
    Date Received
    March 26, 2012
    Date of Event
    January 1, 2010
    Report Date
    February 15, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE LEFT KNEE WAS ORIGINALLY REPLACED ON (B)(6) 2007. EARLY IN 2010, MY LEFT KNEE BEGAN BEING SORE. THIS OCCURRED APPROX ONCE A MONTH AND CONTINUED MONTHLY FOR SOME MONTHS. BY (B)(6) 2010, THE KNEE BECAME VERY PAINFUL REQUIRING THE USE OF A CANE AND WALKING WAS VERY DIFFICULT. I MET WITH DR (B)(6) OF (B)(6) ORTHOPAEDICS IN (B)(6) 2010, THE KNEE WAS XRAYED AND DR (B)(6) STATED SURGERY WAS NECESSARY TO CORRECT THE PROBLEM. (PROCEDURE: REVISION OF LEFT TOTAL KNEE ARTHROPLASTY. SHE DEVELOPED INCREASING PAIN AND DEFORMITY AT THE KNEE WITH RADIOGRAPHIC FINDINGS OF A LOOSE TIBIAL COMPONENT WITH SUBSIDENCE OF THE TIBIAL COMPONENT. DUE TO HER PERSISTANT DYSFUNCTION AND PAIN, SHE WISHED TO DISCUSS UNDERGO REVISION UNDERSTANDING THE RISKS, BENEFITS, LIMITATIONS OF THIS PROCEDURE. ALL QUESTIONS ANSWERED). AFTER RECEIVING CLEARANCES FROM DR (B)(6) (PRIMARY CARE) DR (B)(6) (CARDIOLOGIST) AND DR (B)(6) (DENTIST), THE REPAIR OF THE LEFT KNEE (SURGERY) WAS DONE ON (B)(6) 2016. THE DEFECTIVE DEPUY KNEE PARTS: (FEMUR # 6-CATALOG # 960042; TIBIA INSERT # 96211; ROTATING PLATFORM # 00950385) WHERE REMOVED AND REPLACED WITH A STRYKER KNEE. THE TIBIA WAS COMPLETELY LOOSE WITH AGAIN IMPACTION AND DEPRESSION OF THE MEDIAL SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA TOTAL KNEE FEMORAL JWH DEPUY ORTHOPAEDICS, INC.
    2 SIGMA TOTAL KNEE TIBIA INSERT JWH DEPUY ORTHOPAEDICS, INC.
    3 SIGMA TOTAL KNEE ROTATING PLATFORM JWH DEPUY ORTHOPAEDICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R