MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; GLENOID BASEPLATE - Ø27X15

Model Number	04.01.0154
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The glenosphere screw could not be fully inserted in the baseplate.Residual bone around the baseplate was suspected, and the surrounding area was cleared again, but the same issue occurred.When the screw was inserted without the glenosphere as a test, the screw again stopped midway.The screw was left at the point where it stopped.The surgery was completed implanting the glenosphere with the glenosphere screw not completely screwed.
Additional Manufacturer Narrative
Batch review performed on 3 february 2026.Reverse shoulder system 04.01.0154 glenoid baseplate - d 27x15 (k170452) lot: 2502474: (b)(4) items manufactured and released on 04-jun-2025.Expiration date: 21-may-2030.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 04.01.0173 glenosphere - d 39x27 (k170452) lot: 2513442: (b)(4) items manufactured and released on 13-aug-2025.Expiration date: 29-jul-2030.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.Batch review of the semifinished glenosphere screw lot (of ref 04.01.0173 - lot: 2513442): reverse shoulder system 64.01.9009 sf glenosphere screw lot: 2509824: (b)(4) items manufactured and released on 14-jul-2025.No anomalies found related to the problem.Root cause:due to the lack of information it is not possible to establish a definitive root cause, while the device history record review does not indicate any potentially related manufacturing issue.
Additional Manufacturer Narrative
Clinical evaluation: the intra-operative image provided unfortunately does not allow a detailed assessment of the screw-baseplate interface or the internal thread condition; therefore, it does not provide elements to clarify the cause of the event.With the limited information currently available, it is not possible to determine the exact root cause of why the glenosphere screw could not be fully inserted.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: GLENOID BASEPLATE - Ø27X15
• 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: 24494903
• Report Number: 3005180920-2026-00154
• Device Sequence Number: 12035068
• Product Code: PHX
• UDI-Device Identifier: 07630040706414
• UDI-Public: 07630040706414
• 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): 04/01/2026

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: 04.01.0154
• Device Lot Number: 2502474
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2025
• 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 Age: 77 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian