BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN REMOTION TOTAL WRIST RADIAL IMPLANT

    MDR report key: 8404504 · Received March 8, 2019

    Report

    Report Number
    0008031020-2019-00167
    Event Type
    Injury
    Date Received
    March 8, 2019
    Date of Event
    January 1, 2009
    Report Date
    March 8, 2019
    Manufacturer
    STRYKER GMBH
    Product Code
    KWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE DISPOSITION UNKNOWN.

    Description of Event or Problem · 1

    THE MANUFACTURER BECAME AWARE OF A STUDY FROM (B)(6). THE TITLE OF THIS STUDY IS ¿(B)(6)¿ AND IS ASSOCIATED WITH THE REMOTION TOTAL WRIST SYSTEM. WITHIN THAT PUBLICATION, POST-OPERATIVE COMPLICATIONS/ ADVERSE EVENTS WERE REPORTED, WHICH OCCURRED BETWEEN 2009 AND 2015. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE CATALOGS FROM THE REPORT; 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, 30 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR DIFFERENT ADVERSE EVENTS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES LYSIS. 10 OUT OF 22 CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198978 UNKNOWN REMOTION TOTAL WRIST RADIAL IMPLANT IMPLANT KWN STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention