MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; HUMERAL REVERSE HC LINER Ø36/+6MM

Model Number	04.01.0121
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 month after the primary, the patient came in reporting pain due to a dislocation of the glenosphere from the liner.The surgeon revised the liner, glenosphere and metaphysis.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 09 december 2025.Reverse shoulder system 04.01.0121 humeral reverse hc liner d 36/+6mm (k170452) lot 2336601: (b)(4) items manufactured and released on 12-dec-2023.Expiration date: 2028-11-22.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.Reverse shoulder system 04.01.0169 glenosphere - d 36x24.5 (k170452) lot 2508855: (b)(4) items manufactured and released on 14-july-2025.Expiration date: 2030-06-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event 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.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: HUMERAL REVERSE HC LINER Ø36/+6MM
• 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: 23836931
• Report Number: 3005180920-2025-01250
• Device Sequence Number: 5081115
• Product Code: PHX
• UDI-Device Identifier: 07630040706285
• UDI-Public: 07630040706285
• 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): 12/18/2025

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: 04.01.0121
• Device Lot Number: 2336601
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2023
• 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 Age: 77 YR
• Patient Sex: Female
• Patient Race: White