MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM 04.01.0208 LAT. GLENOSPHERE 39XØ24.5; SHOULDER GLENOSPHERE

Model Number 04.01.0208

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Insufficient Information (4580)

Event Date 04/05/2022

Event Type  Injury  

Event Description

The patient came in for a post-op appointment and it was revealed that the glenosphere eccentricity has shifted superiorly.The surgeon plans to revise the patient on (b)(6) 2022.Primary surgery was performed in (b)(6) 2021.

Manufacturer Narrative

Batch review performed on 29-apr-2022.Lot 2005601a: (b)(4) items manufactured and released on 26-jan-2021.Expiration date: 2026-01-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medical affairs director one year after rsa, at a follow up visit the glenosphere is found rotated versus the initial position.From the radiograph supplied, it appears that it may also have detached in part from the taper spigot of the baseplate.This may be due to incomplete seating of the baseplate fixation screws, to a quasi-traumatic event, or to another factor that we cannot trace with the information at hand.Re-positioning of the glenosphere is highly recommendable if the patient conditions allow.Other device involved: batch review performed on 29-apr-2022.Reverse shoulder system 04.01.0191 threaded glenoid baseplate ø24.5x30 (k171058) lot 1904749: (b)(4) items manufactured and released on 04-dec-2019.Expiration date: 2024-11-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.

Event Description

The patient came in for a post-op appointment and it was revealed that the glenosphere eccentricity has shifted superiorly.After different e-mails on 08.07.2022 we concluded that due to a misunderstanding the all details, event description included are wrong.The patient had nothing wrong, it was not revised and had not any adverse event.

Manufacturer Narrative

Correction: after different e-mails on 08.07.2022 we concluded that due to a misunderstanding the all details, event description included are wrong.The patient had nothing wrong, it was not revised and had not any adverse event.All components are managed as associated items.

• Brand Name: REVERSE SHOULDER SYSTEM 04.01.0208 LAT. GLENOSPHERE 39XØ24.5
• Type of Device: SHOULDER GLENOSPHERE
• 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: 14286985
• MDR Text Key: 290766843
• Report Number: 3005180920-2022-00326
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 07630040728072
• UDI-Public: 07630040728072
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193175
• 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,Followup
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.01.0208
• Device Catalogue Number: 04.01.0208
• Device Lot Number: 2005601A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2022
• Initial Date FDA Received: 05/05/2022
• Supplement Dates Manufacturer Received: 04/05/2022
• Supplement Dates FDA Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/26/2021
• 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