MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA ANATOMIC SHOULDER PROSTHESIS; STANDARD HUMERAL DIAPHYSIS - CEMENTLESS, SIZE 12

Model Number	04.01.0007
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	08/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 26 august 2025.Reverse shoulder system 04.01.0007 standard humeral diaphysis - cementless - 12 (k170910) lot 1905763: (b)(4) items manufactured and released on 18-sep-2019.Expiration date: 2024-08-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Additional components involved and revised (all batch reviews performed on 26 august 2025) reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot 2240213: (b)(4) items manufactured and released on 23-feb-2023.Expiration date: 2028-02-06d.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported events during the period of review.Reverse shoulder system 04.01.0123 humeral reverse hc liner ø39/+3mm (k170452) lot 2238989: (b)(4) items manufactured and released on 03-jan-2023.Expiration date: 2027-12-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Reverse shoulder system 04.01.0154 glenoid baseplate - ø27x15 (k170452) lot 2217814: (b)(4) items manufactured and released on 22-nov-2022.Expiration date: 2027-11-06.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported events during the period of review.Reverse shoulder system 04.01.0159 glenoid polyaxial locking screw - l22 (k170452) lot 2248437: (b)(4) items manufactured and released on 15-feb-2023.Expiration date: 2028-01-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Reverse shoulder system 04.01.0161 glenoid polyaxial locking screw - l30 (k170452) lot 2247053: (b)(4) items manufactured and released on 01-feb-2023.Expiration date: 2028-01-15.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Reverse shoulder system 04.01.0162 glenoid polyaxial locking screw - l34 (k170452) lot 2242294: (b)(4) items manufactured and released on 21-dec-2022.Expiration date: 2027-12-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Reverse shoulder system 04.01.0211 lat.Glenosphere 39xø27 (k193175) lot 2240585: (b)(4) items manufactured and released on 02-dec-2022.Expiration date: 2027-11-20.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.Conclusions: 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 2 years 3 months after the primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all implants, and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: ANATOMIC SHOULDER PROSTHESIS
• Common Device Name: STANDARD HUMERAL DIAPHYSIS - CEMENTLESS, SIZE 12
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 22931703
• Report Number: 3005180920-2025-00844
• Device Sequence Number: 16049764
• Product Code: KWS
• UDI-Device Identifier: 07630040706063
• UDI-Public: 07630040706063
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2025

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: 08/26/2024
• Device Model Number: 04.01.0007
• Device Lot Number: 1905763
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2019
• 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