MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; THREADED GLENOID BASEPLATE Ø24.5X30

Model Number	04.01.0191
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	03/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 9 march 2026.Lot 2116430: (b)(4) items manufactured and released on 26-apr-2022.Expiration date: 12-apr-2027.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event during the period of review.Root cause:as reported, patient's bone quality was the primary cause of the event.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.
Event or Problem Description
On (b)(6) 2026, about 3 years after the previous revision surgery, the patient came in reporting pain due to a loose baseplate (secured with 4 screws) due to poor bone quality.The surgeon revised the threaded baseplate to a grs baseplate, revised the d 36x24.5 glenosphere to a d 42x24.5 glenosphere, and the d 36/+3 reverse liner to a d 42/+6mm liner.The surgery was completed successfully.Bone graft was not used during primary and first revision.The patient had primary right shoulder surgery on (b)(6) 2022.On (b)(6) 2023, the patient came in reporting pain due to a malpositioned baseplate and the cause of the malpositioned baseplate is unknown.The surgeon revised the baseplate, glenosphere and liner.The surgery was completed successfully.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: THREADED GLENOID BASEPLATE Ø24.5X30
• 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: 24738821
• Report Number: 3005180920-2026-00238
• Device Sequence Number: 10421537
• Product Code: PHX
• UDI-Device Identifier: 07630040715478
• UDI-Public: 07630040715478
• Combination Product (Y/N): N
• PMA/510(K) Number: K171058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 03/31/2026

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: 04.01.0191
• Device Lot Number: 2116430
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2022
• 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: 73 YR
• Patient Sex: Female