BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STAR POLYETHYLENE COMPONENT

    MDR report key: 10270690 · Received July 14, 2020

    Report

    Report Number
    0008031020-2020-01900
    Event Type
    Injury
    Date Received
    July 14, 2020
    Date of Event
    January 4, 2012
    Report Date
    July 14, 2020
    Manufacturer
    STRYKER GMBH
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 DUKE UNIVERSITY MEDICAL CENTER, IN USA. THE TITLE OF THIS REPORT IS ¿INTERMEDIATE TO LONG-TERM OUTCOMES OF THE STAR TOTAL ANKLE REPLACEMENT: THE PATIENT PERSPECTIVE¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿SCANDINAVIAN TOTAL ANKLE REPLACEMENT (STAR)¿ SYSTEM. ARTICLE CAN BE FOUND ON HTTP://DX.DOI.ORG/10.2106/JBJS.J.01613. WITHIN THAT PUBLICATION WHICH INCLUDED 82 PATIENTS, POST-OPERATIVE COMPLICATIONS WERE REPORTED, WHICH ALLEGEDLY OCCURRED BETWEEN JULY 1998 TO FEBRUARY 2008. 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 (3) CASES OF REPLACEMENT OF FRACTURED POLYETHYLENE SPACER WITH A NEW SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734790 UNKNOWN STAR POLYETHYLENE COMPONENT PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED NTG STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention