MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; LAT. GLENOSPHERE 42XØ27

Model Number	04.01.0212
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 feb 2026.Reverse shoulder system 04.01.0212 lat.Glenosphere 42xd 27 (k193175) lot 2402058: (b)(4) items manufactured and released on 13-may-2024.Expiration date: 2029-apr-29.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 04.01.0125 humeral reverse hc liner d 42/+0mm (k170452) lot 2346514: (b)(4) items manufactured and released on 12-mar-2024.Expiration date: 2029-feb-21.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.Clinical evaluation performed by r&d project manager.Based on the information provided, the patient presented one year and four months after surgery with pain due to a dislocation of the glenosphere and liner.There was no reported trauma associated with this event.A review of the available radiographic images does not reveal any additional information that would clarify the underlying causes of the dislocation.However, events of this nature are known to commonly arise from progression of soft tissue insufficiency over time or from inadequate restoration of soft tissue tension following the initial operation.These mechanisms are well documented contributors to postoperative instability and can lead to liner or glenosphere dislocation in the absence of trauma.With the elements currently available, no further conclusions can be drawn regarding the event, and there is no evidence to suggest a device malfunction.Root cause:based on the information available no definitive root cause can be established, while 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
At 1 year and 4 months from the patient came in presenting pain due to a dislocation of the glenosphere and liner.There was no reported trauma as a cause.The surgeon revised the metaphysis, glenosphere and liner to a constrained liner.The surgery was completed successfully.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: LAT. GLENOSPHERE 42XØ27
• 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: 24558206
• Report Number: 3005180920-2026-00176
• Device Sequence Number: 9330724
• Product Code: HSD
• UDI-Device Identifier: 07630040728119
• UDI-Public: 07630040728119
• Combination Product (Y/N): N
• PMA/510(K) Number: K193175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/10/2026

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: 04.01.0212
• Device Lot Number: 2402058
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2024
• 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: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Race: White