MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; GLENOSPHERE - Ø36X24.5

Model Number	04.01.0169
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 12 january 2026.Reverse shoulder system 04.01.0169 glenosphere - d 36x24.5 (k170452) lot 2204140: (b)(4) items manufactured and released on 1-jun-2022.Expiration date: 19-may-2027.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 04.01.0119 humeral reverse hc liner d 36/+0mm (k170452) lot 2214337: (b)(4) items manufactured and released on 09-sep-2022.Expiration date: 23-aug-2027.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.Approximately three years after the primary procedure, the patient presented with pain associated with a dislocation of the liner from the glenosphere.The exact cause of this event remains unknown.During the revision surgery, the surgeon elected to upsize both the liner and the glenosphere.Such occurrences are considered consistent with physiological progression of soft tissue degeneration.Based on the information currently available, no further conclusions can be drawn regarding alternative causes or device malfunction.Root cause: the dislocation is a literature-described adverse events following joint arthroplasty.The exact cause could not be determined; however, there is no evidence to suggest that a device design or manufacturing defect contributed to the event, which is most likely related to physiological changes and soft tissue degeneration over time.
Event or Problem Description
At about 3 years from the primary, the patient came in reporting pain due to dislocation of the liner from the glenosphere and the cause is unknown.The surgeon upsized the liner and glenosphere.The surgery was completed successfully.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: GLENOSPHERE - Ø36X24.5
• 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: 24208601
• Report Number: 3005180920-2026-00063
• Device Sequence Number: 15866630
• Product Code: PHX
• UDI-Device Identifier: 07630040706568
• UDI-Public: 07630040706568
• Combination Product (Y/N): N
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 01/29/2026

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: 04.01.0169
• Device Lot Number: 2204140
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2026
• Initial Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2022
• 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: 69 YR
• Patient Sex: Female
• Patient Race: White