MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; GLENOSPHERE - Ø42X27

Model Number	04.01.0174
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by clinical affairs department revision after 3 months from previous rsa surgery due to glenosphere dislocation.A review of the postoperative radiographic images obtained immediately after the reverse shoulder implantation in (b)(6) 2026 suggests that the glenosphere did not appear to be fully seated onto the baseplate taper.In particular, the interface between the glenosphere and the baseplate taper appears suboptimal, which may indicate incomplete engagement at the time of initial implantation.With this information, it can be assumed that the glenosphere may have been insufficiently impacted during the reverse implantation procedure, resulting in a suboptimal initial positioning.Such incomplete taper engagement could potentially compromise the mechanical stability of the glenosphere-baseplate connection and increase the risk of secondary dislocation, particularly under increased loading conditions such as those reported (extensive gardening work).Therefore, with the information at hand, there is no reason to suspect a malfunctioning device.Visual inspection performed by r&d project manager the glenosphere d 42x27 ref.04.01.0174, lot 2507899, presented very minor scratches on the articular surface.Its female taper presented no sign of wear nor usage, thus supporting the clinical evaluation of an incomplete taper engagement.The glenosphere screw presented 7 out of 9 threads heavily blunted, and some minor circular wear marks on its unthreaded portion, probably due to the mechanical loads being transmitted improperly due to the incomplete taper engagement.Batch review performed on 21 april 2026 reverse shoulder system 04.01.0174 glenosphere - d 42x27 (k170452) lot 2507899: (b)(4) items manufactured and released on 11-jun-2025.Expiration date: 27-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 04.01.0154 glenoid baseplate - d 27x15 (k170452) lot 2505898: (b)(4) items manufactured and released on 09-jul-2025.Expiration date: 17-jun-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.Root cause: the most probable root cause of the reported glenosphere dislocation is incomplete seating/engagement of the glenosphere onto the baseplate taper during the implantation procedure, likely due to insufficient impaction.This suboptimal taper engagement may have compromised the mechanical stability of the glenosphere¿baseplate connection and led to secondary dislocation, particularly under increased loading conditions reported by the patient.The device history record review does not indicate any potentially related manufacturing issue.
Event or Problem Description
In (b)(6) 2026, about 3 months after the reverse shoulder implantation, the patient presented at the clinic with complaints following extensive gardening work, and a radiological examination revealed dislocation of the glenosphere.The surgeon revised only the glenosphere.It has been reported that the glenosphere orienter and torque limiter was used during the primary surgery.In (b)(6) 2021, the patient received an anatomical shoulder prosthesis from medacta due to osteoarthritis.Following a bicycle accident in (b)(6) 2026 and the resulting ligament instability, the anatomical prosthesis was replaced with a reverse prosthesis from medacta.The previously implanted stem remained in place.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: GLENOSPHERE - Ø42X27
• 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: 25160339
• Report Number: 3005180920-2026-00396
• Device Sequence Number: 10642557
• Product Code: PHX
• UDI-Device Identifier: 07630040706612
• UDI-Public: 07630040706612
• Combination Product (Y/N): N
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 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: 04.01.0174
• Device Lot Number: 2507899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2025
• 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: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Race: White