BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DISCOVERY ULNAR COMPONENT

    MDR report key: 7976294 · Received October 17, 2018

    Report

    Report Number
    0001825034-2018-09809
    Event Type
    Injury
    Date Received
    October 17, 2018
    Date of Event
    October 1, 2014
    Report Date
    October 17, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWI
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN HUMERAL COMPONENT. REPORT SOURCE - FOREIGN: (B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER AND LOT NUMBER OF THE DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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. R. LARGE, A. TAMBE, T. CRESSWELL, M. ESPAG, D. I. CLARK, FROM THE ROYAL DERBY HOSPITAL, DERBYSHIRE, UNITED KINGDOM. THE JOURNAL OF BONE AND JOINT SURGERY, WWW.JBJS .ORG, VOLUME 96-B, NUMBER 10, OCTOBER 10, 2014; 96-B:1359¿65. DOI:10.1302/0301-620X.96B10. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-09808 - [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT FIVE (5) EVENTS OF RADIOLUCENCIES WERE IDENTIFIED. THESE FIVE PROGRESSED, BUT WITHOUT COMPLETE LOOSENING AND WERE REPORTED TO BE MONITORED. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED AND THE PATIENTS' OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816710 UNKNOWN DISCOVERY ULNAR COMPONENT PROSTHESIS, ELBOW KWI ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other