BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NOTTINGHAM SHOULDER

    MDR report key: 6574349 · Received May 17, 2017

    Report

    Report Number
    3002806535-2017-00386
    Event Type
    Injury
    Date Received
    May 17, 2017
    Date of Event
    December 7, 2015
    Report Date
    September 19, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    MBF
    PMA / PMN Number
    PK060716
    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)(6). 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 K060716. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER AND NO PRODUCT WAS RETURNED. DHR AND COMPLAINT HISTORY COULD NOT BE REVIEWED DUE TO THE LACK OF INFORMATION RECEIVED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT HEMI-ARTHROPLASTY SHOULDER REVISION DUE TO PAIN WITH LIMITED RANGE OF MOBILITY AND GLENOID DEFICIENCY APPROXIMATELY 13 YEARS POST-IMPLANTATION. THE PATIENT WAS REVISED TO AN SRS SYSTEM WITH A CUSTOM GLENOID COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354864 UNKNOWN NOTTINGHAM SHOULDER PROSTHESIS, SHOULDER MBF BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R