BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KINCISE ADAPTOR DEVICES

    MDR report key: 13052484 · Received December 21, 2021

    Report

    Report Number
    1045834-2021-01923
    Event Type
    Injury
    Date Received
    December 21, 2021
    Date of Event
    December 8, 2021
    Report Date
    December 15, 2021
    Manufacturer
    DEPUY SYNTHES PRODUCTS LLC
    Product Code
    GEY
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS MEDWATCH, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED AS APPROPRIATE. THE BRAND NAME IS UNKNOWN. THE MANUFACTURING LOCATION IS UNKNOWN. THE CATALOG NUMBER, LOT/SERIAL NUMBER, AND UNIQUE IDENTIFIER (UDI) IS UNKNOWN. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM (B)(6) THAT A PATIENT HAD A TOTAL HIP REPLACEMENT SURGICAL PROCEDURE USING THE KINCISE SYSTEM (AN ACTIS-STEM WAS IMPLANTED). IT WAS REPORTED THAT AFTER THE SURGERY THE PATIENT WAS SUFFERING FROM A PERONEAL LESION AND A FLOPPY FOOT. IT WAS REPORTED THAT THE LEFT HIP OF THE PATIENT HAD BEEN AFFECTED. IT WAS REPORTED THAT AN ACTIS RASP SIZE 4 WAS USED, AND AN ACTIS STEM SIZE 4 WAS IMPLANTED. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE PROCEDURE OR IF A SPARE DEVICE AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT REPORTED. IT WAS NOT REPORTED WHAT AND/OR IF MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION WAS REQUIRED DUE TO THIS EVENT. THERE WAS NO ALLEGATION OF A MALFUNCTION AGAINST THE DEVICE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1953312 UNKNOWN KINCISE ADAPTOR DEVICES IMPACTOR, ADAPTERS, BATTERY, BATTERY CHARGER GEY DEPUY SYNTHES PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| L