MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; HUMERAL REVERSE HC LINER Ø32/+0MM

Model Number	04.01.0116
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation based on the information provided, the patient underwent revision surgery approximately one year and four months after the primary procedure due to a dislocation at the articulation between the liner and the (competitor) glenosphere.No trauma was reported in association with this event.A review of the available radiographic image does not reveal any additional information that would clarify the underlying cause 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.Batch review performed on 06 july 2026 lot 2402701: (b)(4) items manufactured and released on 28-may-2024.Expiration date: 14-may-2029.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:based on the information available, no definitive root cause can be established.Dislocation is a literature-described adverse event after joint arthroplasty and may be related to case-specific clinical factors, such as soft tissue insufficiency or inadequate restoration of soft tissue tension.There is no indication of a device-related issue, manufacturing issue, or systemic deficiency.
Event or Problem Description
Revision surgery due to joint luxation between liner and competitor glenosphere after about 1 year and 4 months from primary.The surgeon revised liner and metaphysis.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: HUMERAL REVERSE HC LINER Ø32/+0MM
• 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: 25747737
• Report Number: 3005180920-2026-00669
• Device Sequence Number: 16013108
• Product Code: PHX
• UDI-Device Identifier: 07630040706230
• UDI-Public: 07630040706230
• Combination Product (Y/N): N
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 07/08/2026

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: 04.01.0116
• Device Lot Number: 2402701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2024
• 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: 63 YR
• Patient Sex: Female