BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COPELAND SHOULDER

    MDR report key: 5681472 · Received May 26, 2016

    Report

    Report Number
    3002806535-2016-00287
    Event Type
    Injury
    Date Received
    May 26, 2016
    Report Date
    April 29, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWS
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSIONS AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS AND PRODUCT IDENTIFICATION WAS NOT PROVIDED FOR THE PATIENT MENTIONED IN THE JOURNAL ARTICLE. THE FOLLOWING COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF BIRTH - MONTH AND DAY NI, DATE OF EVENT - NI, DEVICE CODE - NI, DEVICE INFO - NI, DATE IMPLANTED - NI, DATE EXPLANTED - NI. (B)(6). MANUFACTURE DATE ¿ NI.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "REVISION OF FAILED HUMERAL HEAD RESURFACING ARTHROPLASTY" WHICH AIMED TO EXAMINE THE OUTCOMES OF A SERIES OF PATIENTS WHO UNDERWENT REVISION SURGERY AFTER HUMERAL HEAD RESURFACING (HHR) AND TO DETERMINE THE RESULTS, COMPLICATIONS, AND RATE OF ADDITIONAL REVISION SURGERY OF PATIENTS WHO UNDERWENT REVISION SURGERY AFTER HHR. A PATIENT WAS IDENTIFIED IN THE ARTICLE THAT WAS REVISED ELEVEN MONTHS POST-IMPLANTATION DUE TO PAIN, INFECTION, AND LOOSENING. A TOTAL SHOULDER ARTHROPLASTY WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336381 UNKNOWN COPELAND SHOULDER PROSTHESIS, SHOULDER KWS BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R