BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL RETAINER 7.5X58

    MDR report key: 226059 · Received June 2, 1999

    Report

    Report Number
    1822565-1999-00051
    Event Type
    Injury
    Date Received
    June 2, 1999
    Date of Event
    April 27, 1999
    Product Code
    GCZ
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    PT HAD LEFT TOTAL KNEE REPLACEMENT IN 1986. IN 1990 PT FELL AND REQUIRED A REVISION OF THIS TOTAL JOINT. NOW SHE PRESENTED WITH SEVERE MEDICAL INSTABILITY WITH A VALGUS DEFORMITY ON THE LEFT. PT ALSO HAD SEVERE PAIN REQUIRING REVISION SURGERY TO REMOVE AND REPLACE. ALL COMPONENTS WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Implant TIBIAL RETAINER 7.5X58 GCZ NA 563812

    Patients

    Seq Age Sex Outcome Treatment
    1