BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RADIAL STEM

    MDR report key: 9965406 · Received April 15, 2020

    Report

    Report Number
    0008031020-2020-01288
    Event Type
    Injury
    Date Received
    April 15, 2020
    Date of Event
    January 1, 2007
    Report Date
    April 15, 2020
    Manufacturer
    STRYKER GMBH
    Product Code
    KXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. DEVICE DISPOSITION IS UNKNOWN.

    Description of Event or Problem · 1

    THE MANUFACTURER BECAME AWARE OF A STUDY FROM (B)(6). THE TITLE OF THIS REPORT IS ¿A-0447 FUNCTIONAL AND RADIOLOGICAL OUTCOMES OF A SINGLE-CENTER SERIES OF 17 WRIST PROSTHESES¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿REMOTION¿ SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED FROM 2007-2011. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE/PATIENT DETAIL FROM THE REPORT, A REVIEW OF THE COMPLAINT HANDLING DATABASE, HOWEVER, REVEALED THAT THE EVENTS HAS NOT BEEN REPORTED BY THE HOSPITAL OR BY THE AUTHOR OF THE PUBLICATION, THEREFORE 7 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REVISION TO WRIST ARTHRODESIS. 3 OUT OF 3 CASES. THE REPORT STATES: ¿WRIST ARTHRODESIS WAS PERFORMED IN THREE PATIENTS.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429289 UNKNOWN RADIAL STEM IMPLANT KXE STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention