MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5; GLENOSPHERE FOR REVERSE SHOULDER SYSTEM

Catalog Number 04.01.0169

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Joint Disorder (2373)

Event Date 02/06/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 18-feb-2020: lot 183800: (b)(4) items manufactured and released on 09-may-2019.Expiration date: 23.04.2024.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs director.Two months after rsa the patient is reoperated in order to change the position of the glenoid components.No mention of a malfunctioning device has been received.Other devices involved in the event: reverse shoulder system 04.01.0151 glenoid baseplate ø24.5x15 lot.1811888 (k170452) batch review performed on 18-feb-2020: lot 1811888: (b)(4) items manufactured and released on 02-may-2019.Expiration date: 21.04.2024.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Reverse shoulder system 04.01.0119 humeral reverse hc liner ø36/+0mm lot.175044 (k170452) batch review performed on 18-feb-2020: lot 175044: (b)(4) items manufactured and released on 27-sep-2017.Expiration date: 11.09.2022.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.

Event Description

Revision surgery performed due to shoulder luxation (glenosphere from the liner) 2 months after the primary.There was an inferior tilt of the glenosphere with the baseplate that led to luxation.The position of the baseplate has been changed and a lateralized glenosphere has been implanted.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 36XØ24.5
• Type of Device: GLENOSPHERE FOR REVERSE SHOULDER SYSTEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 9799364
• MDR Text Key: 190326147
• Report Number: 3005180920-2020-00128
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K170452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2024
• Device Catalogue Number: 04.01.0169
• Device Lot Number: 183800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 03/06/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention