BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STAR TIBIAL COMPONENT

    MDR report key: 10363096 · Received August 4, 2020

    Report

    Report Number
    0008031020-2020-02066
    Event Type
    Injury
    Date Received
    August 4, 2020
    Date of Event
    July 1, 2011
    Report Date
    August 4, 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 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) BONE AND JOINT SPECIALIST, IN USA. THE TITLE OF THIS REPORT IS ¿CORRECTION OF MODERATE TO SEVERE CORONAL PLANE DEFORMITY WITH THE STAR¿ ANKLE PROSTHESIS¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿STAR¿ ANKLE¿ SYSTEM. THE ARTICLE CAN BE FOUND AT HTTPS://DOI.ORG/10.3113%2FFAI.2011.0659. WITHIN THAT PUBLICATION WHICH INCLUDED 130 PATIENTS, POST-OPERATIVE COMPLICATIONS WERE REPORTED, WHICH ALLEGEDLY OCCURRED FROM JANUARY 2000 TO DECEMBER 2009. 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 (2) CASES OF 4 DEGREES OF CORONAL PLANE DEFORMITY RECURRENCE. THE REPORT STATES: ¿OVERALL RECURRENCE OF THE DEFORMITY, DEFINED AS MORE THAN 2 DEGREES IN TALAR ALIGNMENT COMPARED TO THE INITIAL POSTOPERATIVE RADIOGRAPHS, OCCURRED IN 6/43 PATIENTS (14%). THIS RESULTED IN INCONGRUITY BETWEEN THE TIBIA AND TALAR COMPONENTS. THE AMOUNT OF DEFORMITY RECURRENCE OR INCONGRUITY WAS 3 DEGREES (ONE PATIENT), 4 DEGREES (TWO PATIENTS), 5 DEGREES (ONE PATIENT), 9 DEGREES (ONE PATIENT), AND 20 DEGREES (ONE PATIENT). ONE OF THESE PATIENTS UNDERWENT REVISION OF A LOOSE TALAR COMPONENT AT 8.5 YEARS AFTER THE INITIAL REPLACEMENT.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825836 UNKNOWN STAR TIBIAL COMPONENT PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED NTG STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other