BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COPELAND SH HUM SZ4 STND PLUS

    MDR report key: 5706952 · Received June 8, 2016

    Report

    Report Number
    3002806535-2016-00326
    Event Type
    Injury
    Date Received
    June 8, 2016
    Report Date
    May 9, 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. 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. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: DATE OF EVENT - NI. DATE IMPLANTED - DATE NI. INITIAL REPORTER - NAME NI. PMA 510(K): - 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)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K051843. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    PATIENT UNDERWENT AN IRRIGATION AND DEBRIDEMENT PROCEDURE DUE TO PAIN AND INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361367 COPELAND SH HUM SZ4 STND PLUS PROSTHESIS, SHOULDER HSD BIOMET UK LTD. N/A 1382917

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R