MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; GLENOID BASEPLATE - Ø24.5X25

Model Number	04.01.0152
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 02 febr 2026 glenoid baseplate - d 24.5x25 (k170452) lot 2413518: (b)(4) items manufactured and released on 03-sept-2024.Expiration date: 2029-aug-20.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 04.01.0169 glenosphere - d 36x24.5 (k170452) lot 2519720: (b)(4) items manufactured and released on 22-oct-2025.Expiration date: 2030-oct-07.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.(two devices involved in this case) reverse shoulder system 64.01.9009 sf glenosphere screw lot 2423197: (b)(4) items manufactured and released on 31-oct-2024.No anomalies found related to the problem.(two devices involved in this case) investigation performed by r&d project manager.The connection between the baseplate and the glenosphere is achieved through a conical connection between the tapers of the components and secured by the use of a safety screw.The safety screw has to be inserted after the two implants have already been coupled via the taper.In order to be correctly inserted, the axes of the two implants must be aligned.To achieve this, the use of an alignment guide is required.The guide cannot be replaced by using the screw as a guide.The screw does not provide adequate guidance to seat the glenosphere correctly onto the baseplate.Furthermore, using the screw in this way interferes with the proper assembly of the glenosphere to the impactor (04.01.10.0432).
Event or Problem Description
After impacting the glenosphere onto the baseplate, the surgeon attempted to insert the screw, but was unsuccessful.Several attempts, including the use of another glenosphere of the same lot, also failed.The surgeon decided to replace the baseplate.However, during its removal, the glenoid fractured, necessitating the implantation of a cta-type endoprosthesis.Subsequently, outside the operative field, the fit between the glenosphere and the baseplate was tested again, but each time the central screw was tightened, the glenosphere would slip out of the baseplate.Delay time: approximately 30 minutes (total duration 1.5 hours).No info regarding patient`s bone quality.No guide was used forglenosphereinsertion.Retentive glenosphere impactor (ref 04.01.10.0432) used.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: 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: 24454894
• Report Number: 3005180920-2026-00124
• Device Sequence Number: 21324350
• Product Code: PHX
• UDI-Device Identifier: 07630040706391
• UDI-Public: 07630040706391
• Combination Product (Y/N): N
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.01.0152
• Device Lot Number: 2413518
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2024
• 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: Other
• Patient Sex: Unknown