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

Model Number	04.01.0208
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/05/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3005180920-2022-00326
• Device Sequence Number: 14833838
• Product Code: HSD
• UDI-Device Identifier: 07630040728072
• UDI-Public: 07630040728072
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K193175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 01/17/2026
• Device Model Number: 04.01.0208
• Device Catalogue Number: 04.01.0208
• Device Lot Number: 2005601A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown