BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN REMOTION WRIST CARPAL IMPLANT MEDIUM

    MDR report key: 10237404 · Received July 6, 2020

    Report

    Report Number
    0008031020-2020-01847
    Event Type
    Injury
    Date Received
    July 6, 2020
    Date of Event
    June 5, 2020
    Report Date
    July 6, 2020
    Manufacturer
    STRYKER GMBH
    Product Code
    KXE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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.

    Description of Event or Problem · 1

    THE MANUFACTURER BECAME AWARE OF A POST MARKET CLINICAL FOLLOW-UP REPORT RECEIVED FROM (B)(6) HOSPITAL, IN USA. THE TITLE OF THIS REPORT IS ¿A RETROSPECTIVE DATA COLLECTION OF THE REPLACEMENT OF THE TOTAL WRIST JOINT DUE TO RHEUMATOID ARTHRITIS, OSTEO-ARTHRITIS OR POST-TRAUMATIC ARTHRITIS WITH REMOTION TOTAL WRIST SYSTEM¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿REMOTION TOTAL WRIST¿ SYSTEM. THE TREATMENT PERIOD OF PATIENTS INCLUDED IN THIS REPORT WAS BETWEEN (B)(6) 2014 AND (B)(6) 2019. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE DETAILS FROM THE REPORT, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE 7 COMPLAINTS WERE INITIATED RETROSPECTIVELY FOR THE POST-OPERATIVE COMPLICATIONS MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES PAIN THROUGHOUT THE HAND AT NIGHT AND NERVE SENTIVITY AT 6 MONTHS FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695455 UNKNOWN REMOTION WRIST CARPAL IMPLANT MEDIUM IMPLANT KXE STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other