BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EXTREMITY

    MDR report key: 5685940 · Received May 27, 2016

    Report

    Report Number
    3006946279-2016-00097
    Event Type
    Injury
    Date Received
    May 27, 2016
    Report Date
    April 28, 2016
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    HSD
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSIONS AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS AND PRODUCT IDENTIFICATION WERE NOT PROVIDED FOR THE PATIENTS MENTIONED IN THE JOURNAL ARTICLE. THE FOLLOWING COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. DATE OF EVENT - NI, DEVICE PRODUCT CODE - NI, EXPIRATION DATE - NI, DATE IMPLANTED - NI, DATE EXPLANTED - NI, (B)(6), MANUFACTURE DATE ¿ NI. THIS IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENTS (REFERENCE 1825034-2016-01733 & 3006946279-2016-00097).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON A REVIEW OF THE JOURNAL ARTICLE, "ASSOCIATION OF LATERAL HUMERAL OFFSET WITH FUNCTIONAL OUTCOME AND GEOMETRIC RESTORATION IN STEMLESS TOTAL SHOULDER ARTHROPLASTY." THE AIMS OF THIS STUDY WERE TO DETERMINE THE ASSOCIATION OF POSTOPERATIVE LATERAL HUMERAL OFFSET (LHO) CHANGES WITH SHOULDER FUNCTION AND QUALITY OF LIFE AND TO INVESTIGATE THE ABILITY OF STEMLESS ANATOMIC TOTAL SHOULDER ARTHROPLASTY TO RESTORE LHO, HUMERAL HEAD HEIGHT (HH), CENTER OF ROTATION (COR), AND NECK-SHAFT ANGLE (NSA). THE HYPOTHESIS WAS THAT POSTOPERATIVE LHO CHANGES WOULD INFLUENCE SHOULDER FUNCTION AND QUALITY OF LIFE AND THE STEMLESS ANATOMIC TOTAL SHOULDER ARTHROPLASTY (TSA) WOULD RESTORE THE TESTED GEOMETRIC PARAMETERS TO ACCEPTABLE LIMITS. TWO PATIENTS IDENTIFIED IN THE ARTICLE WERE REPORTED TO HAVE BEEN REVISED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340230 UNKNOWN EXTREMITY PROSTHESIS, SHOULDER HSD BIOMET FRANCE S.A.R.L. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R