BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIXED LOCKING SCREW 3.5 HEX

    MDR report key: 6138116 · Received December 1, 2016

    Report

    Report Number
    0001825034-2016-04943
    Event Type
    Injury
    Date Received
    December 1, 2016
    Date of Event
    October 21, 2016
    Report Date
    November 30, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS REPORT IS NUMBER 3 OF 5 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-04938 / 04942 / 04944 / 04945). QUANTITY - 2. CONCOMITANT PRODUCTS: CATALOG #113609, COMPREHENSIVE PRIMARY STEM 9MM, LOT #920270; CATALOG #115370, COMPREHENSIVE REVERSE TRAY 44MM, LOT #377200; CATALOG #115310, COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE, LOT #215200; CATALOG #XL-115363, ARCOM XL HUMERAL BEARING, LOT #839540.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL AND CORRECTED INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT SHOULDER ARTHROPLASTY REVISION DUE TO THE MINI BASEPLATE AND TAPER ADAPTOR DISASSOCIATING AND THE SCREWS LOOSENING FROM THE GLENOID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790049 FIXED LOCKING SCREW 3.5 HEX PROSTHESIS, SHOULDER PAO BIOMET ORTHOPEDICS NA 149470

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R