BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STAR TALAR COMPONENT

    MDR report key: 9525882 · Received December 27, 2019

    Report

    Report Number
    0008031020-2019-02399
    Event Type
    Injury
    Date Received
    December 27, 2019
    Date of Event
    January 1, 1993
    Report Date
    December 27, 2019
    Manufacturer
    STRYKER GMBH
    Product Code
    HSN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT HAS BEEN REPORTED DURING A LITERATURE REVIEW PERFORMED BY THE POST MARKET SURVEILLANCE GROUP. 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 STUDY FROM (B)(6) HOSPITAL, (B)(6). THE TITLE OF THIS REPORT IS 'SURVIVAL ANALYSIS OF THE SINGLE- AND DOUBLE-COATED STAR ANKLE UP TO 20 YEARS: LONG-TERM FOLLOW-UP OF 324 CASES FROM THE (B)(6) ANKLE REGISTRY' WHICH IS ASSOCIATED WITH THE STRYKER STAR PROSTHESIS. WITHIN THAT PUBLICATION, POSTOPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED WHICH OCCURRED BETWEEN 1993 AND 2007. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE OR PATIENT DETAILS FROM THE STUDY, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAVE NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 147 COMPLAINTS WAS INITIATED RETROSPECTIVELY FOR ADVERSE EVENT MENTIONED IN THE STUDY. THIS PRODUCT INQUIRY ADDRESSES DEBRIDEMENT OF THE GUTTERS AND STABILIZATION OF THE ANKLE BY LIGAMENT AUGMENTATION. 6 OUT OF 22 CASES. THE STUDY STATES: "11 SECONDARY SURGICAL PROCEDURES WERE PERFORMED IN EACH DESIGN GROUP, THE MOST COMMON BEING DEBRIDEMENT OF THE GUTTERS AND STABILIZATION OF THE ANKLE BY LIGAMENT AUGMENTATION AND/OR DIFFERENT OSTEOTOMIES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320034 UNKNOWN STAR TALAR COMPONENT IMPLANT HSN STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention