MAUDE Adverse Event Report: Medacta International SA Shoulder System; Short humeral diaphysis - Cementless - 14

Model Number	04.01.0187
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/27/2026
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 a fractured humerus and the cause is unknown.The surgeon revised the reverse metaphysis from +0mm/0° to +9mm/0°, revised the rev.Constrained e-cross liner d 39/+6 to a reverse hc liner d 39/+3mm, and revised the short humeral diaphysis - cementless - 14 to a long humeral diaphysis - l200 - 13.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 31 august 2026 reverse shoulder system 04.01.0187 short humeral diaphysis - cementless - 14 (k180089) 2004311a: (b)(4) items manufactured and released on 22-sep-2025.Expiration date: 02-sep-2030.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Root cause: bone fracture is a 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.

• Brand Name: Shoulder System
• Common Device Name: Short humeral diaphysis - Cementless - 14
• 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: 50692288
• Report Number: 3005180920-2026-00964
• Device Sequence Number: 18563195
• Product Code: PHX
• UDI-Device Identifier: 07630040715959
• UDI-Public: 07630040715959
• Combination Product (Y/N): N
• PMA/510(K) Number: K180089
• 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: 04.01.0187
• Device Lot Number: 2004311A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2025
• 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: Unknown