BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOTINGHM SHLDR HUM HEAD 48X17 OFFSET

    MDR report key: 5377703 · Received January 19, 2016

    Report

    Report Number
    3002806535-2016-00034
    Event Type
    Injury
    Date Received
    January 19, 2016
    Report Date
    December 22, 2015
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWS
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(6) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K992899. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: DATE IMPLANTED - MONTH AND DAY UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A SHOULDER ARTHROPLASTY ON (B)(6) 2004. SUBSEQUENTLY, A REVISION PROCEDURE IS ALLEGEDLY PLANNED TO REMOVE AND REPLACE THE HUMERAL TRAY. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A SHOULDER ARTHROPLASTY IN 2004. SUBSEQUENTLY, A REVISION PROCEDURE IS ALLEGEDLY PLANNED TO REMOVE AND REPLACE THE HUMERAL TRAY. THERE HAS BEEN NO REPORTED REVISION PROCEDURE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36609 NOTINGHM SHLDR HUM HEAD 48X17 OFFSET PROSTHESIS, SHOULDER KWS BIOMET UK LTD. N/A 711908

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention