BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRYKER TRIATHLON CR KNEE

    MDR report key: 10528038 · Received September 14, 2020

    Report

    Report Number
    0002249697-2020-01867
    Event Type
    Injury
    Date Received
    September 14, 2020
    Date of Event
    August 18, 2020
    Report Date
    September 14, 2020
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THIS PI IS FOR PATIENT 10 OF 11. IN AN EXCERPT FROM THE 2018 DKG ANNUAL MEETING, "CRUCIATE RETAINING VERSUS POSTERIOR STABILIZED TOTAL KNEE ARTHROPLASTY FOR THE TREATMENT OF VALGUS OSTEOARTHRITIS?" THE FOLLOWING IS NOTED: "IN THE CR GROUP, 11/97 PATIENTS WERE REVISED DUE TO A.P. INSTABILITY..."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995536 UNKNOWN STRYKER TRIATHLON CR KNEE PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R