MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MSS - HUMERAL REVERSE LINERS; HUM. REV. CONSTRAINED E-CROSS LINER Ø42/+3

Model Number	04.01.0518
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Dislocation (2374); Implant Pain (4561)
Date of Event	06/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had primary right reverse shoulder surgery on (b)(6) 2024.On (b)(6) 2025, the patient came in due to pain due to a fractured acromium and it is unknown how this occured.During surgery, it was determined that the liner had also dislocated from the glenosphere.The surgeon upsized the poly to prevent future dislocation with plans for a future surgery to correct the acromium.The surgery was completed successfully.On (b)(6) 2026, the patient came in reporting pain due to a dislocation of the glenosphere and liner as the result of a fall.The surgeon revised the reverse hc liner d 42/+0mm to a constrained e-cross liner d 42/+3.The surgery was completed successfully.Presently, on (b)(6) 2026, the patient came in presenting pain due to dislocation of the glenosphere from the liner and the cause is unknown.The surgeon converted the reverse shoulder implants to anatomic shoulder implants.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2026 reverse shoulder system 04.01.0518 hum.Rev.Constrained e-cross liner d 42/+3 lot (k250338) 2503944: (b)(4) items manufactured and released on 25-mar-2025.Expiration date: 09-mar-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 04.01.0174 glenosphere - d 42x27° (k170452) lot 1908175: (b)(4) items manufactured and released on 15-jan-2020.Expiration date: 07-jan-2025.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.This is the 3rd revision surgery of the patient, however the glenosphere was not revised in the previous cases, which were only reported as a "post operative discrepancy." for this reason, we consider the event as the 1st case for the lot, and not as reported in the statistics table.Root cause: dislocation is possible literature described adverse event after primary joint arthroplasties and causes are often unknown.There is no indication that any potential issue with the device may have caused or contributed to the event and the investigation does not indicate any potential manufacturing related issue or systemic deficiency.

• Brand Name: MSS - HUMERAL REVERSE LINERS
• Common Device Name: HUM. REV. CONSTRAINED E-CROSS LINER Ø42/+3
• 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: 25747769
• Report Number: 3005180920-2026-00652
• Device Sequence Number: 18663615
• Product Code: PHX
• UDI-Device Identifier: 07630542751158
• UDI-Public: 07630542751158
• Combination Product (Y/N): N
• PMA/510(K) Number: K250338
• 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): 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: 04.01.0518
• Device Lot Number: 2503944
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2025
• 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: 63 YR
• Patient Sex: Male
• Patient Race: White