BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING / STANDARD

    MDR report key: 6241023 · Received January 11, 2017

    Report

    Report Number
    0001825034-2017-00114
    Event Type
    Injury
    Date Received
    January 11, 2017
    Date of Event
    September 17, 2013
    Report Date
    January 10, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 9 STATES, ¿DISLOCATION AND SUBLUXATION DUE TO INADEQUATE FIXATION AND IMPROPER POSITIONING. MUSCLE AND FIBROUS TISSUE LAXITY OR EXCESSIVE ACTIVITY CAN ALSO CONTRIBUTE TO THESE CONDITIONS.¿ MEDICAL PRODUCT - COMPREHENSIVE LOCKING SCREW CATALOG #: 180502 LOT #:388400, COMPREHENSIVE LOCKING SCREW CATALOG #: 180500 LOT #: 828340, COMPREHENSIVE REVERSE CENTRAL SCREW CATALOG #: 115383 LOT #: 843190, COMPREHENSIVE REVERSE SHOULDER 9 IN STEINMANN CATALOG #: 405800 LOT #: 904720, COMPREHENSIVE PRIMARY STEM 10 MM MINI CATALOG #: 113630 LOT #: 114710, COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE STD 36 MM CATALOG #: 115310 LOT #: 603120, COMPREHENSIVE REVERSE FIXED LOCKING SCREW CATALOG #: 180500 LOT #: 172380, COMPREHENSIVE REVERSE TRAY CO 44 MM CATALOG #: 115370 LOT #: 460110, COMPREHENSIVE NON-LOCKING SCREW CATALOG #: 180507 LOT #: 258080, COMPREHENSIVE REVERSE CENTRAL SCREW CATALOG #: 115382 LOT #: 602710. THIS IS 1 OF 2 REPORTS BEING FILED FOR THE SAME PATIENT (REFERENCE 1825034-2017-00114 / 00115). THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    PATIENT'S LEGAL COUNSEL REPORTED THAT PATIENT WAS REVISED APPROXIMATELY 31 DAYS POST-IMPLANTATION DUE TO ALLEGED FAILURE OF DEVICE. 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
    23390 COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING / STANDARD PROSTHESIS, SHOULDER PAO BIOMET ORTHOPEDICS N/A 202280

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R