MAUDE Adverse Event Report: Medacta International SA Shoulder System; Humeral reverse HC liner Ø36/+0mm

Model Number	04.01.0119
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 month from the primary, the patient came in presenting pain due to dislocation of the liner from the glenosphere while making bed.The surgeon revised the d 36x24.5 glenosphere to a d 39x24.5 glenosphere, the metaphysis to a same size metaphysis and the d 36/+0mm liner to a d 39/+5mm liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 24 august 2026 reverse shoulder system 04.01.0119 humeral reverse hc liner d 36/+0mm (k170452) lot 2524252: 90 items manufactured and released on 05-nov-2025.Expiration date: 26-oct-2030.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.Reverse shoulder system 04.01.0169 glenosphere - d 36x24.5 (k170452) lot 2525649: (b)(4)items manufactured and released on 07-jan-2026.Expiration date: 14-dec-2030.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Root cause:implant dislocation is possible literature described adverse event after primary joint arthroplasties and causes are often unknown.There is no indication that any potential issue with the device may have caused or contributed to the event and the investigation does not indicate any potential manufacturing related issue or systemic deficiency.

• Brand Name: Shoulder System
• Common Device Name: Humeral reverse HC liner Ø36/+0mm
• 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: 50692315
• Report Number: 3005180920-2026-00912
• Device Sequence Number: 15851813
• Product Code: PHX
• UDI-Device Identifier: 07630040706261
• UDI-Public: 07630040706261
• Combination Product (Y/N): N
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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: 04.01.0119
• Device Lot Number: 2524252
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2025
• 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
• Patient Race: White