BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERIES I TIBIAL BEARING INSERT

    MDR report key: 2974318 · Received February 22, 2013

    Report

    Report Number
    0002249697-2013-00753
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 1, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    HSX
    PMA / PMN Number
    K862837
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A SCORPIO INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR EVALUATION. MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY REVIEW INDICATE THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED STERILE LOT OR LOT IDS. THE SOURCE OF THE INFECTION COULD NOT BE DETERMINED AS PATIENT INFORMATION, CLINICAL HISTORY, AND RESULTS OF BLOODWORK FOR INFECTION WERE NOT PROVIDED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH INFECTION.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78711 SERIES I TIBIAL BEARING INSERT IMPLANT HSX STRYKER ORTHOPAEDICS-MAHWAH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention