MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; HUMERAL REVERSE HC LINER Ø32/+3MM

Model Number	04.01.0117
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 month from the primary, the patient came in presenting pain due to a dislocation of the liner and glenosphere and the cause is unknown.There was no indication of trauma.The surgeon revised the liner with another one of the same size and revised the metaphysis.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 12 may 2026 reverse shoulder system 04.01.0117 humeral reverse hc liner d 32/+3mm (k170452) lot 2304474: 45 items manufactured and released on 20-jul-2023.Expiration date: 05-jul-2028.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 investigation revision 1 month from the primary, due to a dislocation of the liner and glenosphere and the cause is unknown.There was no reported trauma associated with this event.A review of the available radiographic image 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.The device history record review did not identify any potentially related manufacturing issue.The event may be consistent with case-specific clinical or application-related factors, such as soft tissue insufficiency or inadequate restoration of soft tissue tension following the primary surgery.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: HUMERAL REVERSE HC LINER Ø32/+3MM
• 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: 25313927
• Report Number: 3005180920-2026-00524
• Device Sequence Number: 16087573
• Product Code: PHX
• UDI-Device Identifier: 07630040706247
• UDI-Public: 07630040706247
• 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): 05/28/2026

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: 04.01.0117
• Device Lot Number: 2304474
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2023
• 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 Sex: Male