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

Model Number	04.01.0110
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	05/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The first surgery was successfully performed on (b)(6) 2024, following a primary periprosthetic infection.During the procedure, the surgeon implanted a custom-made glenoid reconstruction.Unfortunately, on (b)(6) 2025, the patient returned with a shoulder dislocation and a recurrent infection.Due to the recurrence of the infection, a significant amount of fluid accumulated in the shoulder joint, which contributed to the dislocation.On (b)(6) 2025, a dair revision surgery was performed to clean the shoulder.During this procedure, the humeral metaphysis and the polyethylene component were replaced in order to resolve the dislocation and restore shoulder stability.
Additional Manufacturer Narrative
Batch review performed on 22 december 2025.Reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot.2406928: (b)(4) items manufactured and released on 06 aug 2024.Expiration date: 22 july 2029.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 04.01.0122 humeral reverse hc liner d 39/+0mm (k170452) lot.2408547: (b)(4) items manufactured and released on 13 june 2024.Expiration date:27 may 2029.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.Clinical evaluation revision after 5 months from the previous surgery due to a dislocation and recurrent infection.In fact, the previous surgery was done due to infection, during which a custom-made glenoid reconstruction was implanted.This is a complex clinical case.The reported events are consistent with progression of the underlying disease affecting the soft tissues and/or insufficient re-establishment of soft tissue tension following surgery.No further conclusions can be drawn based on the available information.Root cause: although a precise root cause cannot be established, the reported events are consistent with progression of the underlying disease affecting the soft tissues and/or insufficient re-establishment of soft tissue tension following surgery.Additionally, the infection detected may have increased the risk of dislocation.There is no indication that any potential issue with the device caused or contributed to the event, and the review of the device history record did not identify any potential manufacturing-related issues.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: HUMERAL REVERSE METAPHYSIS +0MM/0°
• 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: 23864307
• Report Number: 3005180920-2025-01321
• Device Sequence Number: 10006755
• Product Code: PHX
• UDI-Device Identifier: 07630040706179
• UDI-Public: 07630040706179
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

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: 2406928
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2024
• 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: 71 YR
• Patient Sex: Female