MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM

Model Number	04.01.0123
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 october 2025.Reverse shoulder system 04.01.0123 humeral reverse hc liner ø39/+3mm (k170452) lot 2502258: (b)(6) items manufactured and released on 17-apr-2025.Expiration date: 01-apr-2030.No anomalies found related to the problem.To date, (b)(6) items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0154 glenoid baseplate - ø27x15 (k170452) lot 2429838: (b)(6) items manufactured and released on 28-feb-2025.Expiration date: 13-feb-2030.No anomalies found related to the problem.To date, 54 items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0173 glenosphere - ø39x27 (k170452) lot 2432579: 60 items manufactured and released on 24-mar-2025.Expiration date: 09-mar-2030.No anomalies found related to the problem.To date, (b)(6) items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0160 glenoid polyaxial locking screw - l26 (k170452) lot 2403075: (b)(6) items manufactured and released on 21-mar-2024.Expiration date: 27-feb-2029.No anomalies found related to the problem.To date, (b)(6) items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0160 glenoid polyaxial locking screw - l26 (k170452) lot 2416397: (b)(6) items manufactured and released on 16- jul-2024.Expiration date: 03- jul-2029.No anomalies found related to the problem.To date, (b)(6) items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0157 glenoid polyaxial locking screw - l14 (k170452) lot 2503071: (b)(6) items manufactured and released on 24-mar-2025.Expiration date: 09-mar-2030.No anomalies found related to the problem.To date, (b)(6) items of the same lot have been sold with one similar reported event during the period of review.Two devices of the same lot involved in the complaint.Reverse shoulder system 04.01.0007 standard humeral diaphysis - cementless - 12 (k170452) lot 2424860: (b)(6) items manufactured and released on 15-oct-2024.Expiration date: 26-sep-2029.No anomalies found related to the problem.To date, (b)(6) items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot 2430412: (b)(6) items manufactured and released on 10-mar-2025.Expiration date: 19-feb-2030.No anomalies found related to the problem.To date, (b)(6) 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
On (b)(6) 2025 primary surgery was performed.On (b)(6) 2025 1st revision surgery due to implant dislocation (suspected fall) liner revised.On (b)(6) 2025 2nd revision shoulder surgery on the left side due to infection.Explantation of all components and implementation of a competition spacer.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø39/+3MM
• 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: 23424406
• Report Number: 3005180920-2025-01030
• Device Sequence Number: 21298041
• Product Code: PHX
• UDI-Device Identifier: 07630040706308
• UDI-Public: 07630040706308
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• 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: 04.01.0123
• Device Lot Number: 2502258
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2025
• 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: 82 YR
• Patient Sex: Male
• Patient Weight: 110 KG