MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; LAT. GLENOSPHERE 39XØ27

Model Number	04.01.0211
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Post-operative acromion fracture was observed about 2 months after primary surgery.The fracture was identified after the patient reported pain, which led to a consultation and subsequent ct imaging.The fracture will be treated conservatively; no additional/revision surgery planned.No bone graft was used.Nextar was not used for this surgery.
Additional Manufacturer Narrative
Batch review performed on 23 april 2026, lot: 2516903: (b)(4) items manufactured and released on 02-oct-2025.Expiration date: 22-sep-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.Image and planning analysis postoperative ct analysis showed that the surgical procedure differed from the preoperative plan.Intraoperatively, the surgeon elected not to use a bone graft and implanted a d 39 lateralized glenosphere instead of the planned d 36 standard glenosphere, as documented in the complaint description.Assessment of the glenosphere center of rotation on the postoperative ct demonstrated that the implanted d 39 lateralized glenosphere was positioned 2.1 mm more lateral, 2.6 mm more inferior, and 2.8 mm more anterior compared to the planned d 36 standard glenosphere.In addition, the postoperative analysis of the baseplate demonstrated 5°, of anteversion.The humeral stem was implanted with retrotorsion and varus/valgus alignment consistent with the preoperative plan; however, it was positioned approximately 5 mm prouder than planned, resulting in an estimated increase in humeral distalization of 5 mm.The combined effect of the altered glenosphere positioning, the increase in glenosphere size from d 36 to d 39, and the prouder positioning of the humeral stem likely contributed to increased humeral distalization and consequent increased tensioning of the deltoid.Though acromial fracture is reported to be multifactorial and is influenced also by the specific patient conditions (e.G., bone quality, scapular morphology, & hellip;), the increase in deltoid tension may have contributed to the occurrence of the fracture.Image 1.Post-op implants in transparency (light blue), and the planned ones displayed as solid.Root cause: the comparative analysis suggests that differences in implant configuration and positioning may have resulted in increased humeral distalization and, consequently, higher deltoid tensioning.However, acromial fractures are widely recognized to be multifactorial events and may also be influenced by patient-specific factors (e.G., bone quality, scapular morphology).Therefore, the increased deltoid tension can only be considered as a potential contributing risk factor, and it is not possible to identify a definitive root cause for the event.The investigation did not reveal any anomalies in the planning or production and there is no indication that any potential issue with the device may have caused or contributed to the event.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: LAT. GLENOSPHERE 39XØ27
• 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: 25161498
• Report Number: 3005180920-2026-00401
• Device Sequence Number: 10642589
• Product Code: HSD
• UDI-Device Identifier: 07630040728102
• UDI-Public: 07630040728102
• Combination Product (Y/N): N
• PMA/510(K) Number: K193175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 05/13/2026

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: 04.01.0211
• Device Lot Number: 2516903
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2025
• 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: 72 YR
• Patient Sex: Male