MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ27

Model Number	04.01.0173
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 july 2025.Lot 2339653: (b)(4) items manufactured and released on 23-jan-2024.Expiration date: 2029-01-06.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 devices involved: reverse shoulder system 04.01.0122 humeral reverse hc liner ø39/+0mm (k170452) lot.2417035 (b)(4) items manufactured and released on 26-sep-2024.Expiration date: 2029-09-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with two similar reported events during the period of review.Reverse shoulder system 04.01.Cm25.001 reconstr.Reverse glenoid s_hei_rts_cj_27071956 lot.20454p not registered in the us.Clinical evaluation performed by clinical affairs department.The fourth revision surgery has not yet been performed but is planned due to recurrent dislocations.This may be attributed to insufficient restoration of soft tissue tension following the third revision.Based on the available information, no further conclusions can be drawn at this time.Analysis performed by r&d department.The myshoulder case s_hei_rts_cj_27071956 with custom-made implant ref.04.01.Cm25.001 has been reviewed.The surgical plan has been properly carried out and the position of the implant appears to be correct.The medial-lateral position, which is the main parameter which can influence muscle tensioning, has been thoroughly assessed with the surgeon at the planning stage.However, muscle tensioning and joint stability cannot be evaluated in a "preoperative" planning.The implant position in the x-rays seems to be accurate with respect to the "preoperative" plan.
Event or Problem Description
Primary surgery: performed to treat a fracture with a long shaft.Primary date and details unknown.1st revision (due to infection): the surgeon removed only the glenoid, left the shaft in place, and implanted a spacer head with cement.Surgery date and details unknown.2nd revision (custom glenoid implantation): performed on (b)(6) 2025 to implant custom glenoid after the infection was treated.3rd revision (due to shoulder luxation): performed following multiple luxations after the custom implant.It was reported that the revision is due to poor soft tissue tensioning.Surgery date and details unknown.4th revision (planned for (b)(6) 2025): after further dislocations, dr.(b)(6) consulted prof.(b)(6) who will perform a revision surgery in (b)(6).
Event or Problem Description
Primary surgery: performed to treat a fracture with a long shaft.Primary date and details unknown.1st revision (due to infection): dr.(b)(6) removed only the glenoid, left the shaft in place, and implanted a spacer head with cement.Surgery date and details unknown.2nd revision (custom glenoid implantation): performed on (b)(6) 2025 to implant custom glenoid after the infection was treated.Case code: (b)(4).3rd revision (due to shoulder luxation): performed following multiple luxations after the custom implant.It was reported that the revision is due to poor soft tissue tensioning.Surgery date and details unknown.4th revision ((b)(6) 2025 - precise date unknown): after further dislocations, the surgeon consulted with another surgeon, who successfully performed the revision surgery with a retentive liner.
Additional Manufacturer Narrative
On the 1st of october we were informed that the revision surgery was completed successfully and that the liner was exchanged with a retentive one.Updated fields: b2 b5 h11.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ27
• 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: 22574585
• Report Number: 3005180920-2025-00717
• Device Sequence Number: 15873480
• Product Code: PHX
• UDI-Device Identifier: 07630040706605
• UDI-Public: 07630040706605
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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: 2339653
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2024
• 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; Other
• Patient Age: 68 YR
• Patient Sex: Male