MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; HUMERAL REVERSE HC LINER Ø32/+0MM

Model Number	04.01.0116
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On the (b)(6) 2025 the patient undergone reverse shoulder arthroplasty.On the (b)(6) 2025 the patient undergone revision surgery due to joint luxation, liner, diaphysis and metaphysis revised.On the (b)(6) 2025 the patient undergone a second revision surgery due to joint luxation, liner, metaphysis and glenosphere revised.
Additional Manufacturer Narrative
Batch review performed on 14-03-2025: lot 2203294: (b)(4) items manufactured and released on 21-04-2022.Expiration date: 2027-03-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event during the period of review.Additional component involved: lot 2003790a: (b)(4) items manufactured and released on 27-01-2021.Expiration date: 2026-01-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold (1 as lot 2003790b) with one similar reported event during the period of review.The similar event occurred on this lot involved this same device, patient experienced luxation but the glenosphere was not revised (mdr 2025-00219).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, 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: 21709024
• Report Number: 3005180920-2025-00251
• Device Sequence Number: 18660138
• Product Code: PHX
• UDI-Device Identifier: 07630040706230
• UDI-Public: 07630040706230
• 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: 2025
• 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): 03/27/2025

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: 04.01.0116
• Device Lot Number: 2203294
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2022
• 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: Female