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	10/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 jan 2026.Reverse shoulder system 04.01.0185 short humeral diaphysis - cementless - 13 lot.2408538: (b)(4) items manufactured and released on 27 may 2024.Expiration date: 07 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 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot.2408551: (b)(4) items manufactured and released on 09 sep 2024.Expiration date: 25 aug 2029.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0156 glenoid baseplate - d 27x35 (k1704529) lot.2408186 : (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 04.01.0173 glenosphere - d 39x27 (k170452) lot.2409932: (b)(4) items manufactured and released on 05 sep 2024.Expiration date: 21 aug 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 04.01.0122 humeral reverse hc liner d 39/+0mm (k170452) lot.2409942: (b)(4) items manufactured and released on 14 jun 2024.Expiration date: 30 may 2029.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with two similar reported event during the period of review.Reverse shoulder system 04.01.0162 glenoid polyaxial locking screw - l34 ( k170452) lot.2408195: (b)(4) items manufactured and released on 27 may 2024.Expiration date: 25 apr 2029.No anomalies found related to the problem.To date, all items of the same lot have been sold with a similar reported event during the period of review.Reverse shoulder system 04.01.0162 glenoid polyaxial locking screw - l34 ( k170452) lot.2408195: (b)(4) items manufactured and released on 27 may 2024.Expiration date: 25 apr 2029.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with a similar reported event during the period of review.Clinical evaluation: late infection in reverse tsa, approximately 1 year after primary operation.Infection is a known possible adverse event following every surgery, including tsa&size39;s.To date, there is no reason to suspect that the cause may be linked to the implanted devices.Root cause:late infection in tsa is a known possible complication.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 was performed approximately one year after the primary procedure due to a deep infection.All implant components were revised by the surgeon.

• 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: 24162754
• Report Number: 3005180920-2026-00038
• Device Sequence Number: 9252144
• 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: 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): 01/23/2026

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: 2408538
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2024
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 78 KG