MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; HUMERAL REVERSE HC LINER Ø36/+3MM

Model Number	04.01.0120
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	05/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 may 2025: lot 2311275: (b)(4) items manufactured and released on 14-aug-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 events during the period of review.Additional implants involved, batch review performed on 27 may 2025: reverse shoulder system 04.01.0172 glenosphere 36xø27 (k170452) lot 2335894: (b)(4) items manufactured and released on 27-dec-2023.Expiration date: 2028-12-05.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.Reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot 2317072a: (b)(4) items manufactured and released on 20-dec-2023.Expiration date: 2028-11-30.No anomalies found related to the problem.To date, all items of the same lot have been sold with one 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
At about 1 year 2 months after the primary, the patient visit to the hospital due to infection.The patient visited the hospital due to infection.The implants were removed and replaced with new ones.The surgery was completed successfully.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: HUMERAL REVERSE HC LINER Ø36/+3MM
• 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: 22148010
• Report Number: 3005180920-2025-00543
• Device Sequence Number: 7812348
• Product Code: PHX
• UDI-Device Identifier: 07630040706278
• UDI-Public: 07630040706278
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/05/2025

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: 04.01.0120
• Device Lot Number: 2311275
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2023
• 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 Age: 82 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian