MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; REVERSE SHOULDER SYSTEM GLENOSPHERE - Ø39X27

Model Number	04.01.0173
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A not fully seated glenosphere screw was noted from post-operative xrays performed about 3 months post primary surgery.During the surgery, the glenosphere was inserted using the retentive glenosphere impactor over the flexible glenosphere guide.The torque limiting screw driver t15 3nm was used to screw the glenosphere screw into the baseplate.At the moment, there is no intention to perform an additional surgery.
Additional Manufacturer Narrative
Batch review performed on 5 march 2025 lot 2409253: (b)(4) items manufactured and released on 29/08/2024.Expiration date: 07/08/2029.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with two similar reported events during the period of review (the other case is related to complaint (b)(4), reported by the same surgeon).It may be possible that the glenosphere was not correctly aligned and fixed during the primary surgery, but based on the information available no definitive root cause can be established, while the investigation does not indicate any potential manufacturing related issue or systemic deficiency.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: REVERSE SHOULDER SYSTEM GLENOSPHERE - Ø39X27
• 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: 21687568
• Report Number: 3005180920-2025-00210
• Device Sequence Number: 15807582
• Product Code: PHX
• UDI-Device Identifier: 07630040706605
• UDI-Public: 07630040706605
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 03/25/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.01.0173
• Device Lot Number: 2409253
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2024
• 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: Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 98 KG