MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; HUMERAL REVERSE HC LINER Ø42/+0MM

Model Number	04.01.0125
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 july 2025 lot.2305365: (b)(4) items manufactured and released on 03-july-2023.Expiration date: 17-june-2028.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with a similar reported event during the period of review.Additional component invovled and revised: reverse shoulder system 04.01.0212 lat.Glenosphere 42xø27 (k193175) lot.2345639 : (b)(4) items manufactured and released on 07-march-2024.Expiration date: 21-febr-2029.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.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
Primary surgery performed on (b)(6) 2025.1st revision surgery performed on (b)(6) 2025 due to joint luxation; liner and glenosphere revised.2nd revision surgery performed on (b)(6) 2025 due to joint luxation; liner and glenosphere revised.3rd revision surgery performed on (b)(6) 2025 due to joint luxation; liner, glenosphere, and metaphysis revised.Presently, on (b)(6) 2025, the 4th revision surgery has been performed due to joint luxation; patient converted to hemiarthroplasty - glenosphere and baseplate removed, liner and metaphysis replaced with anatomical components.Patient history: primary surgery performed on (b)(6) 2025.1st revision surgery performed on (b)(6) 2025 due to joint luxation; liner and glenosphere revised.(mdr 2025-00721).2nd revision surgery performed on (b)(6) 2025 due to joint luxation; liner and glenosphere revised.(mdr 2025-00720).3rd revision surgery performed on (b)(6) 2025 due to joint luxation; liner, glenosphere, and metaphysis revised.(mdr 2025-00723).4th revision surgery performed on (b)(6) 2025 due joint luxation; patient converted to hemiarthroplasty - glenosphere and baseplate removed, liner and metaphysis replaced with anatomical components (mdr 2025-00719).5th revision surgery performed on (b)(6) 2025 due to intra-prosthetic dislocation (metal humeral head and double eccenter) - humeral head and the double eccentric revised and surrounding bone trimmed using a rongeur.(mdr 2025-00663).

• Brand Name: SHOULDER SYSTEM
• Common Device Name: HUMERAL REVERSE HC LINER Ø42/+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: 22573885
• Report Number: 3005180920-2025-00719
• Device Sequence Number: 9474092
• Product Code: PHX
• UDI-Device Identifier: 07630040706322
• UDI-Public: 07630040706322
• 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: 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): 07/23/2025

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: 04.01.0125
• Device Lot Number: 2305365
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/03/2023
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian