MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+6MM

Model Number	04.01.0124
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	02/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 3 months after the primary, the patient came in reporting pain due to a dislocation of the liner from the glenosphere.The surgeon revised the glenosphere and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 17 september 2024.Lot 2335876: (b)(4) items manufactured and released on 01-dec-2023.Expiration date: 2028-11-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.Addiitonal implant involved.Reverse shoulder system 04.01.0279 sensitin lat.Glenosphere 39xø24.5 (k203755) lot 2302405: (b)(4) items manufactured and released on 24-may-2023.Expiration date: 2028-05-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with two other similar reported events during the period of review.
Additional Manufacturer Narrative
This modifications/additional information reported have been recognized during the check of a complaint on the same patient involved in this case and reported per mdr 005180920-2025-00052.Additional information: involved liner: batch review performed on 17 februray 2025: lot: 2400595: (b)(4) items manufactured and released on 19-apr-2024.Expiration date: 2029-04-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without similar reported event during the period of review.Corrections: the liner lot: 2335876 reported in the initial mdr: (b)(4) was not part of this complaint.Devices implanted on (b)(6) 2024 (6.A.).
Event or Problem Description
The patient had a primary shoulder surgery on (b)(6) 2024.On (b)(6) 2024, the patient came in reporting pain due to a dislocation of the liner from the glenosphere.The surgeon revised the liner and the surgery was completed successfully.On (b)(6) 2024, the patient came in reporting pain due to a dislocation of the liner from the glenosphere.The surgeon revised the liner and the surgery was completed successfully.Presently, on (b)(6) 2024, the patient came in reporting pain due to a dislocation of the liner from the glenosphere.The surgeon revised the glenosphere and liner.The surgery was completed successfully.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+6MM
• 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: 20256798
• Report Number: 3005180920-2024-00766
• Device Sequence Number: 8014144
• Product Code: PHX
• UDI-Device Identifier: 07630040706315
• UDI-Public: 07630040706315
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.01.0124
• Device Catalogue Number: 04.01.0122
• Device Lot Number: 2400595
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2024
• 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: Required Intervention
• Patient Sex: Male