BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVSR SHLDR GLNSP +3 36MM

    MDR report key: 6596207 · Received May 26, 2017

    Report

    Report Number
    0001825034-2017-03466
    Event Type
    Injury
    Date Received
    May 26, 2017
    Date of Event
    May 24, 2016
    Report Date
    June 14, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HSD
    PMA / PMN Number
    PN/A
    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

    CUSTOMER HAS NOT INDICATED WHETHER OR NOT THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. (B)(4). CONCOMITANT 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. THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001825034-2016-04698-1).

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THIS 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
    377089 COMP RVSR SHLDR GLNSP +3 36MM PROSTHESIS, SHOULDER HSD BIOMET ORTHOPEDICS N/A 201430

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R