BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE - SEE PHYSICIAN COMMENTS IN H10.

    MDR report key: 3424804 · Received October 16, 2013

    Report

    Report Number
    3005985723-2013-00080
    Event Type
    Injury
    Date Received
    October 16, 2013
    Date of Event
    September 16, 2013
    Report Date
    September 16, 2013
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON STATED THAT HE FELT THE CAUSE OF THIS REVISION WAS NORMAL PROGRESSION OF OSTEOARTHRITIS DISEASE WITH THIS PT. THE ORIGINAL CASE WAS PERFORMED ON A TGS; CASE SESSION FILES FROM THE TIME OF THE ORIGINAL CASE SIX YRS AGO ARE NOT COMPATIBLE WITH CURRENT SYSTEMS AND WERE NOT ABLE TO BE REVIEWED.

    Description of Event or Problem · 1

    THE PT HAD REC'D A PARTIAL KNEE ARTHROPLASTY, PERFORMED USING THE TACTILE GUIDANCE SYSTEM (TGS, K052851) AND STELKAST'S UNICONDYLAR KNEE SYSTEM (K032824) APPROX SIX YRS PRIOR. THE SURGEON REVISED THE PT TO A TOTAL KNEE REPLACEMENT DUE TO PROGRESSION OF THE PT'S OSTEOARTHRITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531038 NONE - SEE PHYSICIAN COMMENTS IN H10. NONE JWH

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention STELKAST UNICONDYLAR KNEE SYSTEM| TACTILE GUIDANCE SYSTEM (TGS)