BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COMPREHENSIVE REVERSE TAPER

    MDR report key: 6107052 · Received November 16, 2016

    Report

    Report Number
    0001825034-2016-04698
    Event Type
    Injury
    Date Received
    November 16, 2016
    Date of Event
    May 24, 2016
    Report Date
    June 14, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. CONCOMITANT PRODUCTS: MEDICAL PRODUCT - BIOMET HUMERAL TRAY, CATALOG#: 115370, LOT#: 648630; BIOMET BASEPLATE, CATALOG #: 010000589, LOT # 357480; BIOMET MINI HUMERAL STEM, CATALOG#: 113631, LOT#: 253100; BIOMET HUMERAL BEARING, CATALOG#: XL-115363, LOT#: 418390; BIOMET CENTRAL SCREW, CATALOG#: 115395, LOT# 161960; BIOMET FIXED LOCKING SCREW, CATALOG#: 180550, LOT#: 6192920; BIOMET FIXED LOCKING SCREW, CATALOG#: 180551, LOT#: 863450; BIOMET FIXED LOCKING SCREW, CATALOG#: 180552, LOT#: 294240. THERAPY DATE - (B)(6) 2016. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-04697 / 04698).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS PRODUCT DID NOT HAVE TO DO WITH THE INCIDENT AND IS THEREFORE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT REPORTED THAT THE PATIENT UNDERWENT A SHOULDER REVISION APPROXIMATELY FOUR WEEKS POST-IMPLANTATION DUE TO THE GLENOSPHERE TAPER DISASSOCIATING FROM THE GLENOID BASEPLATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756791 UNKNOWN COMPREHENSIVE REVERSE TAPER PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 652700

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R