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	05/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 may 2026 reverse shoulder system 04.01.0123 humeral reverse hc liner d 39/+3mm (k170452) lot: 2514686: (b)(4) items manufactured and released on 29-jul-2025.Expiration date: 10-jul-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 04.01.0170 glenosphere - d 39x24.5 (k170452) lot: 2505967: (b)(4) items manufactured and released on 04-jun-2025.Expiration date: 22-may-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.Root cause: dislocation is possible literature described adverse event after primary hip 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.
Event or Problem Description
At about 5 months from the primary, the patient came in presenting pain from a periprosthetic fracture at the base of the humeral stem due to a fall.The surgeon cabled the fracture and revised the metaphysis from+0mm/0° to +9mm/0° the short diaphysis to a long diaphysis, and the liner changed from 39/+0mmto d 39/+3mm.The surgery was completed successfully.About 2 months later, the patient presented with pain due to dislocation of the liner from the glenosphere and the cause is unknown.No signs of trauma were reported.The surgeon revised the hc liner from d 39/+3mm to a constrained d 39/+0mm.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: 25185355
• Report Number: 3005180920-2026-00466
• Device Sequence Number: 16125457
• 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: 2026
• Device Explanted Year: 2026
• 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): 05/15/2026

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: 04.01.0123
• Device Lot Number: 2514686
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2025
• 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