BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STAR TIBIAL COMPONENT

    MDR report key: 10152855 · Received June 15, 2020

    Report

    Report Number
    0008031020-2020-01646
    Event Type
    Injury
    Date Received
    June 15, 2020
    Date of Event
    May 18, 2015
    Report Date
    June 15, 2020
    Manufacturer
    STRYKER GMBH
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ¿THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER ADDITIONAL INFORMATION IS AVAILABLE. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE AFFECTED LOT NUMBER WAS NOT COMMUNICATED. IF ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE UPDATED. THE REPORTED DEVICE WAS MANUFACTURED AND DISTRIBUTED BY SMALL BONE INNOVATION, INC., (B)(4) AND IMPLANTED BEFORE STRYKER BECAME THE LEGAL MANUFACTURER. ON APRIL 1, 2015 STRYKER BECAME THE LEGAL MANUFACTURER OF THE STAR SYSTEM AND HAS TAKEN THE RESPONSIBILITY FOR THE MEDICAL DEVICE REPORTING.¿ DEVICE DISPOSITION IS UNKNOWN.

    Description of Event or Problem · 1

    THE MANUFACTURER BECAME AWARE OF A LITERATURE PUBLISHED BY (B)(6), USA. THE TITLE OF THIS REPORT IS ¿RADIOGRAPHIC OUTCOMES OF A MOBILE-BEARING TOTAL ANKLE REPLACEMENT¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿SCANDINAVIAN TOTAL ANKLE REPLACEMENT (STAR)¿ SYSTEM. THE ARTICLE CAN BE FOUND WITH PUBMED ID 25970784. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH ALLEGEDLY OCCURRED FROM JULY 1998 TO APRIL 2007. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE DETAILS OR PATIENT INFORMATION FROM THE REPORT, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, 23 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR THE POST-OPERATIVE COMPLICATIONS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES PSEUDOMONAS INFECTION REQUIRING EXPLANTATION. THE REPORT STATES: ¿ONE OF THE EXCLUDED PATIENTS HAD AN EARLY POSTOPERATIVE PSEUDOMONAS INFECTION REQUIRING EXPLANTATION¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617232 UNKNOWN STAR TIBIAL COMPONENT PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED NTG STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention