BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-MODULAR PEGGED GLENOID COMPONENT

    MDR report key: 6585928 · Received May 23, 2017

    Report

    Report Number
    0001825034-2017-03415
    Event Type
    Injury
    Date Received
    May 23, 2017
    Date of Event
    February 28, 2017
    Report Date
    August 8, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK992119
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY THIS REPORT IS A DUPLICATE OF 0001825034-2017-02426.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. UNKNOWN DATE, END OF (B)(6) 2017. DATE IMPLANTED ¿ THE CUSTOMER INDICATED THAT THE DEVICE WAS IMPLANTED ON AN UNKNOWN DATE IN 2006. CONCOMITANT DEVICES - BIO-MODULAR 13.0 MM X 115 MM HUMERAL STEM WITH ALIGNMENT HOLE CATALOG #: 11-113709 LOT #: 874110, BIO-MODULAR HUMERAL HEAD 54 MM X 22 MM DIAMETER CATALOG #: 113722 LOT #: 074400.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT A SHOULDER ARTHROPLASTY REVISION DUE TO LOOSENING OF THE GLENOID COMPONENT APPROXIMATELY ELEVEN (11) YEARS FOLLOWING ORIGINAL IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366352 BIO-MODULAR PEGGED GLENOID COMPONENT PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 004290

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R