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 Laxity (4526)
Date of Event	01/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about one month and a half from primary, the patient came in presenting instability, and the cause is unknown.The surgeon revised the d 32 liner to a d 36+6 constrained liner, and revised the 32xd 24.5 glenosphere to a 36xd 24.5 glenosphere.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 29-jan-2026.Reverse shoulder system 04.01.0116 humeral reverse hc liner d 32/+0mm (k170452) lot.2509657: (b)(4) items manufactured and released on 23-jun-2025.Expiration date: 2030-jun-04.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 04.01.0206 lat.Glenosphere 32xd 24.5 (k193175) lot.2430417: (b)(4) items manufactured and released on 04-apr-2025.Expiration date: 2030-mar-17.No anomalies found related to the problem.To date, (b)(4) tems 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, 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.

• 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: 24399529
• Report Number: 3005180920-2026-00094
• Device Sequence Number: 8158877
• 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): 02/20/2026

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: 2509657
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2025
• 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: 69 YR
• Patient Sex: Female
• Patient Race: White