MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; LAT. GLENOSPHERE 42XØ24.5

Model Number	04.01.0209
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had primary shoulder surgery on (b)(6) 2022.On (b)(6) 2025, the patient came in due to an infection and the pathogen is unknown.The baseplate was left in place.New screws and a new glenosphere were implanted, while the humeral component was from a competitor.The surgery was completed successfully (emdr (b)(4).Presently, on (b)(6) 2026, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the glenosphere to a same size glenosphere.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 02 february 2026.Lot 2403486: (b)(4) items manufactured and released on 27-may-2024.Expiration date: 2029-05-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Root cause: infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: LAT. GLENOSPHERE 42XØ24.5
• 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: 24454890
• Report Number: 3005180920-2026-00110
• Device Sequence Number: 9968733
• Product Code: HSD
• UDI-Device Identifier: 07630040728089
• UDI-Public: 07630040728089
• Combination Product (Y/N): N
• PMA/510(K) Number: K193175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 02/26/2026

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: 04.01.0209
• Device Lot Number: 2403486
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2024
• 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 Age: 71 YR
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Race: White