MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 13

Model Number	04.01.0186
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	09/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Atabout 1 year after the primary surgery in the french mss study “clinical and radiological outcomes of medacta shoulder system”, a total revision surgery was performed due to infection.Medacta products (reverse shoulder system) were implanted during the revision procedure.
Additional Manufacturer Narrative
Batch review performed on 29 april 2026 reverse shoulder system 04.01.0186 short humeral diaphysis - cementless - 13 (k180089) lot 2219878: (b)(4) items manufactured and released on 19-oct-2022.Expiration date: 05-oct-2027.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.Reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot 2405705: (b)(4) items manufactured and released on 26-jul-2024.Expiration date: 10-jul-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.Reverse shoulder system 04.01.0123 humeral reverse hc liner d 39/+3mm (k170452) lot 2404198: (b)(4) items manufactured and released on 23-may-2024.Expiration date: 28-apr-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.Reverse shoulder system 04.01.0155 glenoid baseplate - d 27x25 (k170452) lot 2403805: (b)(4) items manufactured and released on 21-jun-2024.Expiration date: 09-jun-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.Reverse shoulder system 04.01.0211 lat.Glenosphere 39xd 27 (k193175) lot 2403487: (b)(4) items manufactured and released on 21-may-2024.Expiration date: 05-may-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.Reverse shoulder system 04.01.0161 glenoid polyaxial locking screw - l30 (k170452) lot 2409392: (b)(4) items manufactured and released on 27-may-2024.Expiration date: 09-my-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.Reverse shoulder system 04.01.0162 glenoid polyaxial locking screw - l34 (k170452) lot 2411143: (b)(4) items manufactured and released on 16-jun-2024.Expiration date: 02-jun-2024.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.Reverse shoulder system 04.01.0157 glenoid polyaxial locking screw - l14 (k170452) lot 2406656: 50 items manufactured and released on 29-apr-2024.Expiration date: 11-apr-2029.No anomalies found related to the problem.To date, 47 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 2408187: (b)(4) items manufactured and released on 21-may-2024.Expiration date: 02-may-2029.No anomalies found related to the problem.To date, 84 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 2409387: (b)(4) items manufactured and released on 03-jun-2024.Expiration date: 09-may-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.Root cause: 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.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 13
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 25185340
• Report Number: 3005180920-2026-00445
• Device Sequence Number: 10653235
• Product Code: PHX
• UDI-Device Identifier: 07630040715942
• UDI-Public: 07630040715942
• Combination Product (Y/N): N
• PMA/510(K) Number: K180089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/15/2026

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: 04.01.0186
• Device Lot Number: 2219878
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2022
• 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 Age: 79 YR
• Patient Sex: Male
• Patient Weight: 74 KG