MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA 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	12/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 december 2025 reverse shoulder system 04.01.0123 humeral reverse hc liner d 39/+3mm (k170452) lot 2409260: (b)(4) items manufactured and released on 31-may-2024.Expiration date: 2029-05-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Reverse shoulder system 04.01.0279 sensitin lat.Glenosphere 39xd 24.5 (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 three similar reported events during the period of review.Root cause:although a precise root cause cannot be established, these events are generally related to insufficient re-establishment of soft tissue tension after surgery.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 manufacturing-related issue.
Event or Problem Description
The patient had primary right shoulder surgery on (b)(6) 2023.On (b)(6)2025, the patient came in reporting pain and when reviewing the patient’ simplants to prepare for the revision, the repobserved that a 27 glenosphere was implanted with a 24.5mm baseplate during the primary (which is a non-compatible combination as reported in the surgical technique).It is unknown how or why this occurred.Glenosphere, liner and metaphysis revised successfully.Presently, on (b)(6) 2025, the patient came due to dislocation and the cause is unknown.The surgeon revised the liner to a constrained liner.The surgery was completed successfully.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: HUMERAL REVERSE HC LINER Ø39/+3MM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 23858634
• Report Number: 3005180920-2025-01264
• Device Sequence Number: 5030866
• Product Code: PHX
• UDI-Device Identifier: 07630040706308
• UDI-Public: 07630040706308
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/19/2025

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: 2409260
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 12/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2024
• 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: 79 YR
• Patient Sex: Male
• Patient Race: White