BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRYKER TRIATHLON CR KNEE

    MDR report key: 10528035 · Received September 14, 2020

    Report

    Report Number
    0002249697-2020-01862
    Event Type
    Injury
    Date Received
    September 14, 2020
    Date of Event
    March 1, 2015
    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. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    THIS PI IS FOR PATIENT 1 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
    995532 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