MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMIC SHOULDER PROSTHESIS; HUMERAL ANATOMICAL METAPHYSIS-CEMENTLESS-135°-7

Model Number	04.01.0024
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year and 10 months from the primary, the patient came in due to signs of infection and the pathogen is unknown.The surgeon revised the anatomical shoulder to a reverse shoulder.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 07 april 2026 anatomical shoulder system 04.01.0024 humeral anatomical metaphysis-cementless-135°-7 (k170910) lot 1910132: (b)(4) tems manufactured and released on 07-jul-2020.Expiration date: 21-jun-2025.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event during the period of review.Anatomical shoulder system 04.01.0090 metal humeral head d 40 (k170910) lot 2301922: (b)(4) items manufactured and released on 08-nov-2023.Expiration date: 22-oct-2028.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event during the period of review.Anatomical shoulder system 04.01.0128 hc pegged glenoid d 40 (k170910) lot 2309355: (b)(4) items manufactured and released on 22-sep-2023.Expiration date: 04-sep-2028.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event during the period of review.Anatomical shoulder system 04.01.0180 short humeral diaphysis - cementless - 7 (k180089) lot 2335898: (b)(4) items manufactured and released on 08-nov-2023.Expiration date: 15-oct-2028.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one 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: ANATOMIC SHOULDER PROSTHESIS
• Common Device Name: HUMERAL ANATOMICAL METAPHYSIS-CEMENTLESS-135°-7
• 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: 24964780
• Report Number: 3005180920-2026-00356
• Device Sequence Number: 18765964
• Product Code: KWS
• UDI-Device Identifier: 07630040712620
• UDI-Public: 07630040712620
• Combination Product (Y/N): N
• PMA/510(K) Number: K170910
• 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): 04/23/2026

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 Expiration Date: 06/21/2025
• Device Model Number: 04.01.0024
• Device Lot Number: 1910132
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2020
• 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: Female