BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITAN TOTAL SHOULDER SYSTEM

    MDR report key: 3804662 · Received March 4, 2014

    Report

    Report Number
    1651501-2014-00012
    Event Type
    Malfunction
    Date Received
    March 4, 2014
    Report Date
    February 12, 2014
    Manufacturer
    ASCENSION ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    K100448
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED A REVISION OF THE TOTAL SHOULDER SYSTEM WAS RECENTLY PERFORMED. WHEN THE SURGEON REMOVED THE METAL HEAD FROM THE BODY THERE WAS METAL DEBRIS VISIBLE. THE INITIAL SURGERY WAS PERFORMED ONE YEAR EARLIER. THE PRESS-FIT STEM AND BODY IMPLANTS' METAL HAD BEEN COMPROMISED CAUSING THE IMPLANTS TO BE SLIGHTLY DEFORMED'. A REVISION WAS PERFORMED USING THE REVERSE SHOULDER SYSTEM. THE EXPLANTED DEVICES WERE REPORTEDLY DISCARDED BY THE FACILITY AS WASTE. 'ONCE THE EX-PLANT WAS REMOVED THE REVISION SURGERY CONTINUED PERFECTLY.' TOTAL SHOULDER SYSTEM USED THE FOLLOWING: BOD-0920-020-14STD HUMERAL BODY, SIZE 14 STANDARD LOT# 102896; MHH-0920-010-4818E HUMERAL HEAD, ECC, SIZE 48X18MM LOT# 111206; STEM-0920-025-15 HUMERAL STEM, 15 MM LOT # 102507 BSW-0920-021-01 HUMERAL BODY SCREW LOT# 111320; GN 092003002P GLENOID PEG, MEDIUM LOT# 102762. ADDITIONAL INFO WAS REQUESTED BY INTEGRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130564 TITAN TOTAL SHOULDER SYSTEM TITAN SHOULDER SYSTEM KWS ASCENSION ORTHOPEDICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention