BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COPELAND RESURFACING SHOULDER

    MDR report key: 6568811 · Received May 16, 2017

    Report

    Report Number
    3002806535-2017-00382
    Event Type
    Injury
    Date Received
    May 16, 2017
    Date of Event
    June 9, 2015
    Report Date
    May 16, 2017
    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

    (B)(4). 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 K051843. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS UNABLE TO BE REVIEWED WITHOUT LOT NUMBER. NO REVIEW OF THE COMPLAINT HISTORY COULD BE CONDUCTED WITHOUT PRODUCT ID. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER ARTHROPLASTY REVISION DUE TO UNKNOWN REASONS. THE PATIENT WAS REVISED TO A COMPREHENSIVE PROXIMAL SRS SYSTEM. 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
    351748 UNKNOWN COPELAND RESURFACING SHOULDER PROSTHESIS, SHOULDER HSD BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R