BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULNAR SCREW

    MDR report key: 8184172 · Received December 20, 2018

    Report

    Report Number
    0001825034-2018-11310
    Event Type
    Injury
    Date Received
    December 20, 2018
    Date of Event
    November 27, 2018
    Report Date
    January 4, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KXE
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS AND PHOTOGRAPHS. THE POROUS PART OF THE RADIAL STEM SHOWED SOME BONE GROWTH. THE RADIAL BODY IS WORN POSSIBLY DUE TO LOOSENED CARPAL HEAD. DAMAGE ON BACK OF RADIAL BODY POSSIBLY HAPPENED DURING EXPLANTATION. X-RAYS REVIEWED SHOWED SUGGESTION OF LOOSENING OF THE RADIAL COMPONENT AND EVENTUAL SUBSIDENCE OF THE CARPAL COMPONENT. BACKING OUT OF THE ULNAR SCREW ALSO SEEN AS A RESULT. DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS LOT NUMBER IS UNKNOWN. A DEFINITE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE WAS REQUESTED BUT NOT RETURNED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: PART # UNK, RADIAL BODY, LOT # UNK, PART # UNK, CARPAL PLATE, LOT # UNK, PART # UNK, RADIAL STEM, LOT # UNK, PART # UNK, CAPITATE STEM, LOT # UNK, PART # UNK, CARPAL HEAD, LOT # UNK, PART # UNK, RADIAL SCREW, LOT # UNK. EVENT OCCURRED IN (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 11304, 0001825034 - 2018 - 11305, 0001825034 - 2018 - 11306, 0001825034 - 2018 - 11307, 0001825034 - 2018 - 11308, 0001825034 - 2018 - 11309.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 8 YEARS POST IMPLANTATION, THE PATIENT HAD REPORTS OF SWELLING AND PAIN TO THE WRIST. DURING THE FIRST-STAGE REVISION, THE SURGEON HAD DISCOVERED LOOSENING, MIGRATION AND FRACTURING OF THE SCREWS, AND LOCAL METALLOSIS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022629 ULNAR SCREW PROSTHESIS, WRIST KXE ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R