MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; 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	01/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15-jan-2026.Lot 2404591: (b)(4) items manufactured and released on 10-jun-2024.Expiration date: 2029-05-21.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:aseptic loosening is a possible literature-described adverse event after primary shoulder 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.No previous case has been addressed to a device design or manufacturing related root cause.
Event or Problem Description
At about 8 months from primary the patient reported instability, during surgery, the surgeon observed that the baseplate was loose.Bone quality was not an issue.The surgeon revised the baseplate, liner, glenosphere and metaphysis.The surgery was completed successfully.
Additional Manufacturer Narrative
On 10 march 2026, the branch informed us that a bone graft was not used during the primary surgery and 3 screws were used to secure the baseplate.This information has been included in the event description.
Event or Problem Description
At about 8 months from primary the patient reported instability, during surgery, the surgeon observed that the baseplate was loose.Bone quality was not an issue.The surgeon revised the baseplate, liner, glenosphere and metaphysis.The surgery was completed successfully.Bone graft was not used during the primary surgery and 3 screws were used to secure the baseplate.

• Brand Name: SHOULDER SYSTEM
• 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: 24208584
• Report Number: 3005180920-2026-00051
• Device Sequence Number: 13175114
• 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: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: 04.01.0190
• Device Lot Number: 2404591
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2024
• 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: 57 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Race: White