BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COPELAND HEMIARTHROPLASTY SHOULDER

    MDR report key: 6048833 · Received October 21, 2016

    Report

    Report Number
    3002806535-2016-00795
    Event Type
    Injury
    Date Received
    October 21, 2016
    Report Date
    September 23, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    HSD
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. 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 COPLAND HEMI SHOULDER IS NOT CLEARED FOR DISTRIBUTION IN THE U.S.; HOWEVER, THIS REPORT IS BEING FILED AS ZIMMER BIOMET IN THE U.S. MANUFACTURES A SIMILAR DEVICE UNDER 510K NUMBER K051843. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH SINCE THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE MAY BE NECESSARY. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING A REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND, IF WARRANTED, FURTHER MEDWATCH REPORTS WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PATIENT HAS BEEN INDICATED FOR A REVISION WITH CUSTOM COMPONENTS DUE TO GLENOID BONE LOSS. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698666 UNKNOWN COPELAND HEMIARTHROPLASTY SHOULDER PROSTHESIS, SHOULDER HSD BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention