MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA THREADED GLENOID BASEPLATE; THREADED GLENOID BASEPLATE Ø24.5X25

Model Number	04.01.0190
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	10/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year from primary, the patient came in reporting pain.The surgeon, suspecting impingement, removed the poly, cup and glenosphere.Upon attempting to place a new glenosphere, the surgeon noticed the baseplate was loose.The surgeon did not find any fractures and cause of loosineng could not be established.The surgeon revised the glenosphere, liner, metaphysis, and baseplate with medacta implants.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 20-10-2025.Reverse shoulder system 04.01.0190 threaded glenoid baseplateø24.5x25 (k171058) lot 185488a: (b)(4) items manufactured and released on 01-mar-2024 expiration date: 2029-02-13.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: THREADED GLENOID BASEPLATE
• Common Device Name: THREADED GLENOID BASEPLATE Ø24.5X25
• 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: 23478286
• Report Number: 3005180920-2025-01068
• Device Sequence Number: 10228744
• Product Code: PHX
• UDI-Device Identifier: 07630040708098
• UDI-Public: 07630040708098
• Combination Product (Y/N): N
• PMA/510(K) Number: K171058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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: 04.01.0190
• Device Lot Number: 185488A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2024
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Race: White