MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; REVERSE SHOULDER SYSTEM GLENOSPHERE - Ø39X27

Model Number	04.01.0173
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526); Medical device site infection (4845)
Date of Event	03/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24-03-2025 lot 2418600: (b)(4) items manufactured and released on 20-11-2024.Expiration date: 2029-11-05.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.Additional implants revised.Batch review performed on 24-03-2025 on reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot.2419184.Lot 2419184: (b)(4) items manufactured and released on 02-10-2024.Expiration date: 2029-09-15.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.Batch review performed on 24-03-2025 on reverse shoulder system 04.01.0124 humeral reverse hc liner ø39/+6mm (k170452) lot.2311276.Lot 2311276: (b)(4) items manufactured and released on 14-08-2023.Expiration date: 2028-07-29.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
Revision surgery due to infection and instability, patient reported also dislocation.Glenosphere, liner and the metaphysis revised.Primary surgery performed by dr (b)(6) on the (b)(6)2021.Implantation of reverse shoulder components + bone graft and with a cemented standard humeral stem.Myshoulder planning only (m_mic_rts_yb_04031948).1st revision surgery performed on the (b)(6) 2024.Explantation of all primary components.Reimplantation of new reverse shoulder components + bone graft and with a long humeral stem.2nd revision surgery performed on the (b)(6) 2024.Explantation of the long humeral stem with the metaphysis and the liner + explantation of the glenosphere (to test the stability of the baseplate and the graft).Reimplantation of a new long humeral stem (cemented) with a new metaphysis and liner +6mm (155 degrees) + implantation of a new glenosphere (lateralized).3rd revision surgery performed on the (b)(6) 2024.Explantation of all components except the long humeral stem.Implantation of a glenoid custom implant on the (b)(6) 2024 with my shoulder planning (m_mou_rts_yb_04031948).4th revision surgery performed on the (b)(6) 2025.Explantation of the glenosphere, the liner and the metaphysis.Implantation of new components (same sizes).5th revision surgery performed on the (b)(6) 2025.Explantation of the glenosphere, the liner and the metaphysis.Implantation of new components (new same glenosphere but new metaphysis +9mm and liner 39/+3mm).

• Brand Name: SHOULDER SYSTEM
• Common Device Name: REVERSE SHOULDER SYSTEM GLENOSPHERE - Ø39X27
• 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: 21771301
• Report Number: 3005180920-2025-00285
• Device Sequence Number: 13302335
• Product Code: PHX
• UDI-Device Identifier: 07630040706605
• UDI-Public: 07630040706605
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 04/04/2025

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: 04.01.0173
• Device Lot Number: 2418600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2024
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 85 KG