MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; HUMERAL REVERSE HC LINER Ø42/+6MM

Model Number	04.01.0127
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 august 2025 reverse shoulder system 04.01.0127 humeral reverse hc liner ø42/+6mm (k170452) lot.2307538: (b)(4) items manufactured and released on 08-aug-2023.Expiration date: 18-jul-2028.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.Clinical evaluation at about 1 year and 7 months the patient came in reporting pain due to a dislocation of the liner from the glenosphere.These events are normally caused by the progression of disease to the soft tissues or the insufficient re-establishment of soft tissue tension after the operation.No further conclusion can be drawn with the elements at hand.Additional component involved (not revised) reverse shoulder system 04.01.0209 lat.Glenosphere 42xø24.5 (k193175) lot.2103993: (b)(4) items manufactured and released on 01-jul-2021.Expiration date: 16-jun-2026.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with three similar reported events during the period of review (one previous case is related to the same patient).(batch review performed on 11 august 2025) conclusions: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
The patient had a primary shoulder surgery on (b)(6) 2023.On (b)(6) 2025, the patient came in reporting pain due to a dislocation of the liner for the glenosphere.The cause of the dislocation is unknown.The surgeon revised the glenosphere and liner, and the surgery was completed successfully.(mdr 2023-01105) on (b)(6) 2024, the patient came in reporting pain due to a dislocation of the liner for the glenosphere.The cause of the dislocation is unknown.The surgeon revised the glenosphere and liner and the surgery was completed successfully.(mdr 2024-00134) on (b)(6) 2024, the patient came in reporting pain due to a dislocation of the liner for the glenosphere.The cause of the dislocation is unknown.The surgeon revised the liner and the surgery was completed successfully.(mdr 2024-00693) presently, on (b)(6) 2025, at about 1 year and 7 months from the primary, the patient came in reporting pain due to a dislocation of the liner from the glenosphere.The cause of the dislocation is unknown.The surgeon revised only the liner, and the surgery was completed successfully.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: HUMERAL REVERSE HC LINER Ø42/+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: 22770679
• Report Number: 3005180920-2025-00669
• Device Sequence Number: 18538055
• Product Code: PHX
• UDI-Device Identifier: 07630040706346
• UDI-Public: 07630040706346
• 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: 2025
• 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): 08/11/2025

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: 04.01.0127
• Device Lot Number: 2307538
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2023
• 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