MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMIC SHOULDER PROSTHESIS; STANDARD HUMERAL DIAPHYSIS - CEMENTLESS - 13

Model Number	04.01.0008
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 february 2026.Reverse shoulder system 04.01.0008 standard humeral diaphysis - cementless - 13 (k170452) lot 2309345: (b)(4) items manufactured and released on 30-jun-2023.Expiration date: 07-jun-2028.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 2349509: (b)(4) items manufactured and released on 22-may-2024.Expiration date: 01-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 04.01.0124 humeral reverse hc liner d 39/+6mm (k170452) lot 2303290: (b)(4) items manufactured and released on 17-jul-2023.Expiration date: 28-jun-2028.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 04.01.0154 glenoid baseplate - d 27x15 (k170452) lot 2318876: (b)(4) items manufactured and released on 17-jul-2023.Expiration date: 28-jun-2028.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 2348686: (b)(4) items manufactured and released on 04-mar-2024.Expiration date: 17-feb-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.
Event or Problem Description
At about 1 year and 6 months from the primary, the patient came in due to signs of infection and the pathogen is unknown.The surgeon removed all medacta components and implanted antibiotic cement spacers.The surgery was completed successfully.

• Brand Name: ANATOMIC SHOULDER PROSTHESIS
• Common Device Name: STANDARD 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: 24454884
• Report Number: 3005180920-2026-00160
• Device Sequence Number: 18634063
• Product Code: PHX
• UDI-Device Identifier: 07630040706070
• UDI-Public: 07630040706070
• Combination Product (Y/N): N
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 02/26/2026

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: 04.01.0008
• Device Lot Number: 2309345
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2023
• 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 Sex: Male