MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM 04.01.0190 THREADED GLENOID BASEPLATE Ø24.5X25; SHOULDER THREADED GLENOID BASEPLATE

Model Number	04.01.0190
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	01/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in reporting pain due to a malpositioned baseplate 5 months after the primary surgery.The surgeon revised the baseplate, poly, glenosphere and metaphysis.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 01-feb-2023.Lot 2113522: (b)(4) items manufactured and released on 10-dec-2021.Expiration date: 2026-11-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: REVERSE SHOULDER SYSTEM 04.01.0190 THREADED GLENOID BASEPLATE Ø24.5X25
• Common Device Name: SHOULDER THREADED GLENOID BASEPLATE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16349595
• Report Number: 3005180920-2023-00056
• Device Sequence Number: 15027765
• Product Code: PHX
• UDI-Device Identifier: 07630040708098
• UDI-Public: 07630040708098
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K171058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2023

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 Model Number: 04.01.0190
• Device Catalogue Number: 04.01.0190
• Device Lot Number: 2113522
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2021
• 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