BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CARPAL BALL IMPLANT

    MDR report key: 10659104 · Received October 9, 2020

    Report

    Report Number
    0008031020-2020-02308
    Event Type
    Injury
    Date Received
    October 9, 2020
    Date of Event
    September 9, 2020
    Report Date
    October 9, 2020
    Manufacturer
    STRYKER GMBH
    Product Code
    KWN
    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. DEVICE DISPOSITION UNKNOWN.

    Description of Event or Problem · 1

    THE MANUFACTURER BECAME AWARE OF A POST MARKET CLINICAL FOLLOW-UP REPORT RECEIVED FROM THE (B)(6) CENTER, IN USA. THE TITLE OF THIS REPORT IS ¿REMOTION TOTAL WRIST ARTHROPLASTY: RETROSPECTIVE EVALUATION OF OUTCOMES DURING THE FIRST POSTOPERATIVE YEAR¿ WHICH IS ASSOCIATED WITH THE STRYKER ¿REMOTION TOTAL WRIST SYSTEM¿. THIS STUDY INCLUDES RESEARCH DONE ON 21 PATIENTS REQUIRING SURGERY BETWEEN THE PERIOD 2014 AND 2019. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE DETAILS FROM THE REPORT, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, NEW COMPLAINT WAS INITIATED IN THE SYSTEM FOR THE POST-OPERATIVE COMPLICATION MENTIONED IN THE REPORT. THIS PRODUCT INQUIRY ADDRESSES REDUCTION OF ARC OF ACTIVE WRIST FLEXION-EXTENSION FROM PRE-OPERATIVE (50) TO POST-OPERATIVE (40).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124372 UNKNOWN CARPAL BALL IMPLANT IMPLANT KWN STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other