MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER REVERSE SYSTEM; GLENOSPHERE - Ø36X24.5

Model Number	04.01.0169
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Four months after the primary surgery, the patient presented with pain due to a dislocation of the liner from the glenosphere.The surgeon revised both the liner and the glenosphere, and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2025.Reverse shoulder system 04.01.0169 glenosphere - ø36x24.5 (k170452) lot.2417910: (b)(4) items manufactured and released on 22 nov 2024.Expiration date: 06 nov 2029.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 04.01.0119 humeral reverse hc liner ø36/+0mm (k170452) lot.230753: (b)(4) items manufactured and released on 08 august 2023.Expiration date: 23 july 2028.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: based on the information available no definitive root cause can be established, while 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 potential manufacturing related issue.

• Brand Name: SHOULDER REVERSE SYSTEM
• Common Device Name: GLENOSPHERE - Ø36X24.5
• 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: 23478279
• Report Number: 3005180920-2025-01089
• Device Sequence Number: 10228740
• Product Code: PHX
• UDI-Device Identifier: 07630040706568
• UDI-Public: 07630040706568
• 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): 11/05/2025

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: 04.01.0169
• Device Lot Number: 2417910
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2024
• 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 Sex: Male
• Patient Weight: 91 KG
• Patient Race: White