MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0°

Model Number	04.01.0110
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	04/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13-05-2025: lot 2318252a: (b)(4) items manufactured and released on 13-12-2023 expiration date: 2028-11-26.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Additional devies involved.Batch review performed on 13-05-2025: reverse shoulder system 04.01.0123 humeral reverse hc liner ø39/+3mm (k170452) lot 2312761: (b)(4) items manufactured and released on 14-08-2023 expiration date: 2028-07-25.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 04.01.0191 threaded glenoid baseplate ø24.5x30 (k171058) lot 2310105: (b)(4) items manufactured and released on 27-09-2023 expiration date: 2028-09-06.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 04.01.0208 lat.Glenosphere 39xø24.5 (k193175) lot 2318703: (b)(4) items manufactured and released on 13-12-2023 expiration date: 2028-11-21.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 04.01.0187 short humeral diaphysis - cementless - 14 (k180089) lot 2103583: (b)(4) items manufactured and released on 12-05-2021 expiration date: 2026-04-22.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.Infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.
Event or Problem Description
The patient had a primary shoulder surgeon on (b)(6) 2023.On (b)(6) 2024 the patient came in reporting pain due to a torn rotator cuff that was caused from falling.The surgeon converted the patient from anatomic to reverse.The surgery was completed successfully.Complaint (b)(4) was filed.Presently, on (b)(6) 2025, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all implants, and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +0MM/0°
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 22087863
• Report Number: 3005180920-2025-00498
• Device Sequence Number: 12499690
• Product Code: PHX
• UDI-Device Identifier: 07630040706179
• UDI-Public: 07630040706179
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/27/2025

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: 04.01.0110
• Device Lot Number: 2318252A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2023
• 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: Unknown