MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; SHOULDER SHORT HUMERAL DIAPHYSIS - CEMENTLESS - SIZE 11

Model Number	04.01.0184
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	03/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to infection at about 3 months from surgery, part of clinal study.Surgeon revised all components.
Additional Manufacturer Narrative
Batch review performed on 07-02-2025.Lot 2215691: (b)(4) items manufactured and released on 13-09-2022.Expiration date: 2027-08-29.No anomalies found related to the problem.To date, all of the same lot have been sold with no similar reported event during the period of review.Additional implants revised.Batch review performed on 07-02-2025 on reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452 ) lot.2314740a.Lot 2314740a: (b)(4) items manufactured and released on 29-11-2023.Expiration date: 2028-11-15.No anomalies found related to the problem.To date, all of the same lot have been sold with no similar reported event during the period of review.Batch review performed on 07-02-2025 on reverse shoulder system 04.01.0122 humeral reverse hc liner ø39/+0mm (k170452 ) lot.2315001.Lot 2315001: (b)(4) items manufactured and released on 11-09-2023.Expiration date: 2028-08-26.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.Batch review performed on 07-02-2025 on reverse shoulder system 04.01.0155 glenoid baseplate - ø27x25 (k170452 ) lot.2315778.Lot 2315778: (b)(4) items manufactured and released on 16-11-2023.Expiration date: 2028-10-29.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.Batch review performed on 07-02-2025 on reverse shoulder system 04.01.0173.Glenosphere - ø39x27 (k170452 ) lot.2314177.Lot 2314177: (b)(4) items manufactured and released on 19-10-2023.Expiration date: 2028-09-30.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.Batch review performed on 07-02-2025 on reverse shoulder system 04.01.0161 glenoid polyaxial locking screw - l30 (k170452 ) lot.2247096.Lot 2247096: (b)(4) items manufactured and released on 15-02-2023.Expiration date: 2028-01-27.No anomalies found related to the problem.To date, all of the same lot have been sold with one similar reported event during the period of review.Batch review performed on 07-02-2025 on reverse shoulder system 04.01.0161 glenoid polyaxial locking screw - l30 (k170452 ) lot.2315017.Lot 2315017: (b)(4) items manufactured and released on 06-09-2023.Expiration date: 2028-08-15.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported event during the period of review.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: SHOULDER SYSTEM
• Common Device Name: SHOULDER SHORT HUMERAL DIAPHYSIS - CEMENTLESS - SIZE 11
• 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: 21353185
• Report Number: 3005180920-2025-00100
• Device Sequence Number: 15723121
• Product Code: KWS
• UDI-Device Identifier: 07630040715928
• UDI-Public: 07630040715928
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K180089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2025

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 Model Number: 04.01.0184
• Device Lot Number: 2215691
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2022
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 91 KG