BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOM REVERSE HUMERAL LINER

    MDR report key: 6361361 · Received February 27, 2017

    Report

    Report Number
    3006946279-2017-00047
    Event Type
    Injury
    Date Received
    February 27, 2017
    Date of Event
    January 30, 2017
    Report Date
    February 27, 2017
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    KWS
    PMA / PMN Number
    PK060694
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE ¿ NI, MANUFACTURE DATE ¿ NI. THIS DEVICE IS NOT MANUFACTURED BY ZIMMER BIOMET IN THE UNITED STATES; HOWEVER, WE ARE FILING THIS REPORT AS ZIMMER BIOMET MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K060694.

    Description of Event or Problem · 1

    DURING A RIGHT SHOULDER ARTHROPLASTY, THE HUMERAL LINER WOULD NOT SEAT. THIS RESULTED IN A 90 MINUTE DELAY. FRACTURE OF THE HUMERAL DIAPHYSIS WAS ALSO DISCOVERED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143831 CUSTOM REVERSE HUMERAL LINER PROSTHESIS, SHOULDER KWS BIOMET FRANCE S.A.R.L. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention