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	03/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26-03-2025.Lot 2348689: (b)(4) items manufactured and released on 28-03-2024.Expiration date: 2029-03-12.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.Preliminary investigation performed by r&d department.The liner dissociated from the reverse metaphysis due to failure of the coupling between the two components.Givn the information at hand ti is not possible to determine the root cause of the event.The device history record review does not indicate any potentially related manufacturing issue.Additional implants involved batch review performed on 26-03-2025 on reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot.2414237 lot 2414237: (b)(4) items manufactured and released on 13-09-2024.Expiration date: 2029-09-02.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.Batch review performed on 26-03-2025 on reverse shoulder system 04.01.0400 grs baseplate - ø24.5x20 - full wedge 10 (k231911) lot.2315761 lot 2315761: (b)(4) items manufactured and released on 10-07-2024.Expiration date: 2029-06-23.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.Batch review performed on 26-03-2025 on reverse shoulder system 04.01.0208 lat.Glenosphere 39xø24.5 (k193175) lot.2404990 lot 2404990: (b)(4) items manufactured and released on 17-06-2024.Expiration date: 2029-05-27.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.
Event or Problem Description
The patient had a primary shoulder surgery on (b)(6) 2025.On (b)(6) 2025, the patient came in reporting pain due to a dislocation of the liner from the glenosphere and the cause is unknown.The surgeon revised the liner.The surgery was completed successfully.Presently, on (b)(6) 2025, the patient came in reporting pain due to a dislocation.During the surgery, the surgeon noticed that the liner had dissociated from the metaphysis.The surgeon upsized the liner and the surgery was completed successfully.The surgeon reported that he encountered no issue during the first revision with the coulpling of the liner, which was implanted with 145° inclination.Patient was a muscular one.Additionally, reviewing the details of the primary surgery it was noticed that a not cleared combination of implants was used, namely: grs baseplate - full wedge 10 with lat.Glenosphere.

• 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: 21888365
• Report Number: 3005180920-2025-00296
• Device Sequence Number: 3553295
• Product Code: PHX
• UDI-Device Identifier: 07630040706308
• UDI-Public: 07630040706308
• 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: 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): 04/23/2025

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: 2348689
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2024
• 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: 66 YR
• Patient Sex: Male