BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TC-PLUS SOLUTION

    MDR report key: 845466 · Received April 26, 2007

    Report

    Report Number
    2086141-2007-00019
    Event Type
    Injury
    Date Received
    April 26, 2007
    Date of Event
    October 10, 2005
    Report Date
    March 27, 2007
    Manufacturer
    PLUS ORTHOPEDICS AG
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PLUS ORTHOPEDICS HAS RECEIVED NOTIFICATION THAT A REVISION SURGERY TOOK PLACE IN 2005, INVOLVING A PLUS ORTHOPEDICS PRODUCT. REPORTEDLY THE PT EXPERIENCED PAIN AND LIMITED RANGE OF MOTION DURING HER RECOVERY FOLLOWING THE 2005, SURGERY. EVENTUALLY, SHE HAD A REVISION SURGERY ON HER LEFT KNEE SEVEN MONTHS LATER, AND "AT THAT TIME HER DR DISCOVERED THAT THE FEMORAL COMPONENT OF THE KNEE REPLACEMENT PROSTHESIS WAS GROSSLY LOOSE AND HAD NOT BEEN CEMENTED AS DESIGNED". ADDITIONAL DETAIL IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TC-PLUS SOLUTION JWH JWH PLUS ORTHOPEDICS AG 21036 0201.13.0497

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention