BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRIDE UNICONDYLAR KNEE SYSTEM

    MDR report key: 5217750 · Received November 11, 2015

    Report

    Report Number
    3010266064-2015-00004
    Event Type
    Injury
    Date Received
    November 11, 2015
    Date of Event
    October 12, 2015
    Report Date
    April 23, 2020
    Manufacturer
    BLUE BELT TECHNOLOGIES, INC.
    Product Code
    HSX
    UDI-DI
    00841153100168
    PMA / PMN Number
    K123380
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN IT WAS EXPLANTED, WE FOUND THE LOOSENING OF THE COMPONENT WAS DUE TO EXCESSIVE CEMENT ON THE POSTERIOR ASPECT OF THE PROSTHESIS. THE ABUNDANT AMOUNT OF CEMENT CREATED LIFT IN THE POSTERIOR ASPECT AND LOOSENED THE ANTERIOR PORTION. THE POLY DID NOT HAVE ANY CRACKS, BUT HAD SOME SLIGHT INDENTATION. AFTER TAKING THE IMPLANT OUT, THE PHYSICIAN RESIZED THE TIBIA AND FOUND HE WANTED TO MOVE FROM THE ORIGINAL TIBIA SIZE OF A 9 (PFSI-00018) TO AN 8 (PFSI-00016). THE POLY SIZE E, 8MM (PFSI-00045) WAS REPLACED WITH A SIZE D, 8MM (PFSI-00039) THE SAME. HE RE-DRILLED FOR THE TIBIAL PEGS AND BEFORE CEMENTING THE NEW IMPLANT PHYSICIAN TOOK THE SMALLEST DRILL POINT AVAILABLE AND MADE ADDITIONAL HOLES. HE DID THIS, AS HE EXPLAINED, TO BETTER HOLD THE COMPONENT.

    Description of Event or Problem · 1

    PHYSICIAN CONDUCTED A REVISION OF A PATIENT THAT RECEIVED A STRIDE IMPLANT IN LATE MAY. THE PATIENT CAME TO PHYSICIAN COMPLAINING OF TIBIAL PAIN. AN X-RAY WAS DONE ON THE PATIENT AND THE PHYSICIAN CAME TO THE CONCLUSION THAT REVISION NEEDED TO BE DONE BECAUSE OF LOOSENING OF THE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746386 STRIDE UNICONDYLAR KNEE SYSTEM UNICONDYLAR KNEE IMPLANT HSX BLUE BELT TECHNOLOGIES, INC. 110039 C7449321 00841153100168

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention