MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM

Model Number	04.01.0123
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09-apr-2025 (b)(4) items manufactured and released on 08-oct-2024.Expiration date: 19-sep-2029.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Additional implants revised: reverse shoulder system 04.01.0173 glenosphere - ø39x27 (k170452) lot.2418602 batch review performed on 09-apr-2025: (b)(4) items manufactured and released on 11-dec-2024.Expiration date:20-nov-2029.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Root cause: 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 surgery on the (b)(6) 2021.The surgeon implanted reverse shoulder components and bone graft with a cemented standard humeral stem.Myshoulder planning was used (b)(4).On the (b)(6) 2024, the patient undergone a first revision due to infection (propioni-bacterium).Explantation of all primary components.Reimplantation of new reverse shoulder components and bone graft and with a long humeral stem.On the (b)(6) 2024, the patient has been revised for the second time because of joint luxation and loosening of the diaphysis.Explantation of stem, metaphysis, liner and also the glenosphere was removed in order to test the stability of the baseplate and the graft.Implantation of a long humeral stem (cemented), metaphysis, liner +6mm (155 degrees) and lateralized glenosphere.On the (b)(6) 2024, the patient has been revised for the 3rd time due to grs baseplate loosening.Explantation of all components except the long humeral stem.Implantation of a glenoid custom implant on the (b)(6) 2024 with myshoulder planning (b)(4).On the (b)(6) 2025, 4th revision surgery performed due to infection.Explantation of the glenosphere, the liner and the metaphysis.Implantation of new components (same sizes).Subsequently, on the (b)(6) 2025, the patient has been revised for the 5th time because of infection and instability.Moreover, it was reported a join luxation.Explantation of the glenosphere, liner and metaphysis.Implantation of new components.On the (b)(6) 2025, the patient has been revised due to joint luxation.No loosening of the components.Explantation of the liner 39/+3mm 145 degrees.Reimplantation of a new liner 39/+3mm but 155 degrees.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM
• 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: 21928711
• Report Number: 3005180920-2025-00341
• Device Sequence Number: 13017197
• Product Code: PHX
• UDI-Device Identifier: 07630040706308
• UDI-Public: 07630040706308
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 04/29/2025

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: 04.01.0123
• Device Lot Number: 2419701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2024
• 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 Age: 77 YR
• Patient Sex: Male
• Patient Weight: 85 KG