BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STAR TIBIAL COMPONENT

    MDR report key: 10257775 · Received July 10, 2020

    Report

    Report Number
    0008031020-2020-01871
    Event Type
    Injury
    Date Received
    July 10, 2020
    Date of Event
    February 1, 2000
    Report Date
    July 10, 2020
    Manufacturer
    STRYKER GMBH
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 (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 KAISER FOUNDATION HOSPITAL, IN USA. THE TITLE OF THIS REPORT IS ¿GUTTER IMPINGEMENT AFTER TOTAL ANKLE ARTHROPLASTY¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿SCANDINAVIAN TOTAL ANKLE REPLACEMENT (STAR)¿ SYSTEM. THE ARTICLE CAN BE FOUND AT HTTPS://WWW.NCBI.NLM.NIH.GOV/PUBMED/23520289. WITHIN THAT PUBLICATION WHICH INCLUDED 137 PATIENTS, POST-OPERATIVE COMPLICATIONS EVENTS WERE REPORTED, WHICH ALLEGEDLY OCCURRED FROM FEBRUARY 2000 TO JUNE 2011. 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, NEW COMPLAINTS WERE INITIATED IN THE SYSTEM FOR THE POST-OPERATIVE COMPLICATIONS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES DEBRIDEMENT AFTER SECONDARY GUTTER RESECTION (SGR). THE REPORT STATES: ¿SEVEN OF ALL 34 PATIENTS (21%) HAD ADDITIONAL SURGERY RELATED TO THE ANKLE REPLACEMENT AFTER SGR (3 HAD REPEAT DEBRIDEMENT THE 3 PATIENTS WITH REPEAT DEBRIDEMENTS HAD THEIR SECOND SGR AT 5, 15, AND 32 MONTHS LATER, RESPECTIVELY.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724683 UNKNOWN STAR TIBIAL COMPONENT PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED NTG STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention