BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COPELAND SHOULDER

    MDR report key: 6493006 · Received April 14, 2017

    Report

    Report Number
    3002806535-2017-00213
    Event Type
    Injury
    Date Received
    April 14, 2017
    Report Date
    April 14, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    HSD
    PMA / PMN Number
    PK051843
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET US AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K051843. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED [REMAINS IMPLANTED AT THIS TIME] TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS BEEN INDICATED FOR A SHOULDER REVISION DUE TO GLENOID WEAR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274595 UNKNOWN COPELAND SHOULDER SHOULDER, PROSTHESIS HSD BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R