MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; HUMERAL REVERSE HC LINER Ø39/+0MM

Model Number	04.01.0122
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	03/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 31 march 2026: reverse shoulder system 04.01.0122 humeral reverse hc liner d 39/+0mm (k170452) lot: 2505029: (b)(4) items manufactured and released on 22-may-2025.Expiration date: 2030-may-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 1 similar reported event during the period of review.Reverse shoulder system 04.01.0170 glenosphere - d 39x24.5 (k170452) lot: 2518003: (b)(4) items manufactured and released on 21-oct-2025.Expiration date: 2030-oct-01.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 04.01.0402 grs baseplate - d 24.5x20 - full wedge 20° (k231911) lot: 2339044: (b)(4) items manufactured and released on 27-jan-2025.Expiration date: 2030-jan-27.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, 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.
Event or Problem Description
The patient had a shoulder infection and the pathogen is unknown.At about 1 month from primary the surgeon performed a washout and debridement.The surgeon also revised the d 39 liner to a same size liner and revised the d 39x24.5 glenosphere to a same size glenosphere.The surgery was completed successfully.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: HUMERAL REVERSE HC LINER Ø39/+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: 24871722
• Report Number: 3005180920-2026-00318
• Device Sequence Number: 21301744
• Product Code: PHX
• UDI-Device Identifier: 07630040706292
• UDI-Public: 07630040706292
• 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): 04/14/2026

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: 04.01.0122
• Device Lot Number: 2505029
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2025
• 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 Sex: Male
• Patient Race: White