MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMIC SHOULDER PROSTHESIS; HUMERAL ANATOMICAL METAPHYSIS-CEMENTLESS-135°-11

Model Number	04.01.0028
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	06/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had primary left shoulder surgery on (b)(6) 2023.On (b)(6) 2026, the patient came in due to instability as the result of a loose baseplate.The confirmed cause is infection with the pathogen unknown.The surgeon took cultures for testing and revised the reverse shoulder to anatomical with antibiotic spacers.The surgery was completed successfully.Presently, on (b)(6) 2026, the patient came in due to continued signs of infection with the pathogen unknown.The surgeon performed a washout and converted the patient back to a reverse shoulder system.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 2 july 2026 anatomical shoulder system 04.01.0028 humeral anatomical metaphysis-cementless-135° -11 (k170910) lot 2349404: (b)(4) items manufactured and released on 02-may-2024.Expiration date: 07-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.Anatomical shoulder system 04.01.0091 metal humeral head d 42 (k170910) lot 2341999: (b)(4) items manufactured and released on 04-mar-2024.Expiration date: 19-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.

• Brand Name: ANATOMIC SHOULDER PROSTHESIS
• Common Device Name: HUMERAL ANATOMICAL METAPHYSIS-CEMENTLESS-135°-11
• 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: 25778115
• Report Number: 3005180920-2026-00695
• Device Sequence Number: 10686876
• Product Code: KWS
• UDI-Device Identifier: 07630040712668
• UDI-Public: 07630040712668
• Combination Product (Y/N): N
• PMA/510(K) Number: K170910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 07/10/2026

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: 04.01.0028
• Device Lot Number: 2349404
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2024
• 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 Sex: Female