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

Model Number	04.01.0185
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	02/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to infection, at about 4 months post primary the surgeon revised all the devices successfully.
Additional Manufacturer Narrative
Batch reviews performed on 13 february 2026: reverse shoulder system 04.01.0185 short humeral diaphysis - cementless - 13 (k180089) lot 2502815: (b)(4) items manufactured and released on 07-mar-2025.Expiration date: 2030-feb-17.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 reverse metaphysis +0m /0° (k170452) lot 2503358: (b)(4) items manufactured and released on 25-jun-2025.Expiration date: 2030-jun-30.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 04.01.0122 humeral reverse hc liner d 39/+0mm (k170452) lot 2505029: (b)(4) items manufactured and released on 22-may-2025.Expiration date: 2030-may-30.No anomalies found related to the problem.To date, (b)(4) tems 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 2434209: (b)(4) items manufactured and released on 18-mar-2025.Expiration date: 2030-mar-02.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 04.01.0173 glenosphere - d 39x27 (k170452) lot 2504245: (b)(4) items manufactured and released on 23-apr-2025.Expiration date: 2030-apr-23.No anomalies found related to the problem.To date, (b)(4) tems 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 2505909: (b)(4) items manufactured and released on 06-may-2025.Expiration date: 2030-apr-21.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 2500008: (b)(4) items manufactured and released on 17-mar-2025.Expiration date: 2030-feb-24.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: 24494915
• Report Number: 3005180920-2026-00157
• Device Sequence Number: 17416215
• Product Code: PHX
• UDI-Device Identifier: 07630040715935
• UDI-Public: 07630040715935
• Combination Product (Y/N): N
• PMA/510(K) Number: K180089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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): 03/03/2026

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: 04.01.0185
• Device Lot Number: 2502815
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2025
• 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: 87 YR
• Patient Sex: Male
• Patient Weight: 72 KG