MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X30; SHOULDER GLENOID BASEPLATE

Catalog Number	04.01.0191
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	07/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 years and 6 months after primary, the patient came in reporting pain due to instability of the glenoid and the cause is unknown.Moreover, there was evidence of radiolucency around the peripheral screws and central screw.The surgeon revised the glenosphere, screws, baseplate, poly and metaphysis.The surgery was completed successfully.The liner and metaphysis had to be removed in order to have access to the glenosphere and baseplate.
Additional Manufacturer Narrative
Batch review performed on 06-aug-2024: lot 1908238: 50 items manufactured and released on 06-may-2020.Expiration date: 2025-04-22.No anomalies found related to the problem.To date, 49 items of the same lot have been sold with no similar reported event during the period of review.Addiitonal implant involved, batch review performed on 06-aug-2024: reverse shoulder system 04.01.0169 glenosphere - ø36x24.5 (k170452) lot 2105861: 194 items manufactured and released on 25-aug-2021.Expiration date: 2026-07-27.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X30
• Common Device Name: SHOULDER 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: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19947300
• Report Number: 3005180920-2024-00603
• Device Sequence Number: 15293906
• Product Code: PHX
• UDI-Device Identifier: 07630040715478
• UDI-Public: 07630040715478
• Combination Product (Y/N): N
• 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: 2024
• 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): 08/09/2024

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: 04/22/2025
• Device Catalogue Number: 04.01.0191
• Device Lot Number: 1908238
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2020
• 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