BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE SHOULDER SYSTEM HUMERAL DIAPHYSIS CEMENTLESS SIZE 8

    MDR report key: 8399585 · Received March 7, 2019

    Report

    Report Number
    3005180920-2019-00131
    Event Type
    Injury
    Date Received
    March 7, 2019
    Date of Event
    February 7, 2019
    Report Date
    March 7, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    PHX
    UDI-DI
    07630040706025
    PMA / PMN Number
    K170452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 07 MARCH 2019: LOT 176935: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-NOV-2017. EXPIRATION DATE: 2022-10-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. TWO ADDITIONAL ITEMS WERE INVOLVED IN THE COMPLAINT: REVERSE SHOULDER SYSTEM 04.01.0110 HUMERAL REVERSE METAPHYSIS +0MM/0° LOT 174652 (K170452): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-MAR-2018. EXPIRATION DATE: 2023-02-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. REVERSE SHOULDER SYSTEM 04.01.0127 HUMERAL REVERSE HC LINER Ø42/+6MM LOT 173411 (K170452): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JUN-2017. EXPIRATION DATE: 2022-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF INSTABILITY PROBABLY BECAUSE OF LOOSE SOFT TISSUE TENSION 2 WEEKS AFTER A FIRST REVISION OF DJO PRODUCTS WITH MEDACTA HUMERUS DEVICES. THE SURGEON REVISED THE MEDACTA LINER, METAPHYSIS AND DIAPHYSIS AND THE SURGERY WAS COMPLETED SUCCESSFULLY. INITIAL SURGERY WAS A PRIMARY REVERSE WITH DJO. THE PATIENT'S DJO PROSTHESIS BASEPLATE CENTRAL SCREW BROKE. THE PATIENT HAS BEEN REVISED TO (2ND SURGERY) MEDACTA HUMERUS AND TORNIER BASEPLATE AND GLENOSPHERE. THIRD PROCEDURE (THIS CASE IN QUESTION) THE BASEPLATE AND GLENOSPHERE IN WERE TORNIER, THEN WAS REVISED TO TORNIER. MEDACTA HUMERUS WAS REMOVED AND PLACED IN A MORE RETROVERTED POSITION AND UPSIZED WITH ALL NEW COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193280 REVERSE SHOULDER SYSTEM HUMERAL DIAPHYSIS CEMENTLESS SIZE 8 SHOULDER HUMERAL DIAPHYSIS CEMENTLESS PHX MEDACTA INTERNATIONAL SA 176935 07630040706025

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention