BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON P/A CR BEADED #5L

    MDR report key: 18603253 · Received January 29, 2024

    Report

    Report Number
    0002249697-2024-00156
    Event Type
    Injury
    Date Received
    January 29, 2024
    Date of Event
    December 12, 2023
    Report Date
    January 29, 2024
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    UDI-DI
    07613327040982
    PMA / PMN Number
    K051380
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: DEVICE NAME#UNKNOWN_TRIATHLON COMPONENT ; CAT#UNKNOWN ; LOT#UNKNOWN IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE.

    Description of Event or Problem · 0

    AS REPORTED VIA MEDWATCH MW5149272 AND MW5149273 (REPORTS ARE THE SAME WITH A DIFFERENT IMPLANT FOR EACH REPORT): I HAD TOTAL KNEE IMPLANT ON MY LEFT LEG. I HAVE BEEN HAVING PROBLEM WITH IT SINCE DAY ONE. NOW THE BONE SCAN INDICATES THAT THE IMPLANT IS SHOWING THAT IT IS LOOSE AND MY DOCTOR IS RECOMMENDING REPLACE THE TOTAL KNEE IMPLANT. MY IMPLANT CATALOG NUMBER IS THE SAME AS IN THIS RECALL LETTER; CLASS 2 DEVICE RECALL TRIATHLON TRITANIUM TIBIAL COMPONENT, SEE RELATED INFORMATION DATE INITIATED BY FIRM MARCH 30, 2022. DATE POSTED JUNE 3, 2022, RECALL STATUS1 OPEN3, CLASSIFIED RECALL NUMBER Z-1237-2022; RECALL EVENT ID 90241 510(K) NUMBER K123486...I HAVE MY OPERATIVE REPORTS FROM THE HOSPITAL, AND MY DOCTOR WAS INDICATE THAT THIS IMPLANT WAS INSTALLED. I HAVE BEEN SCHEDULED FOR A REVISION SURGERY FOR 2023. NOTE: CATALOG NUMBERS PROVIDED IN THE RECALL NOTICE WERE NOT REPORTED IN EITHER MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2548678 TRIATHLON P/A CR BEADED #5L PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 07613327040982

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H