MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; REVERSE SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 14

Model Number	04.01.0187
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	04/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review no devices lot have been received, nor other additional information about the case.A follow up will be performed if more info about the incident will be available.Other devices involved reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) reverse shoulder system 04.01.0122 humeral reverse hc liner ø39/+0mm (k170452) reverse shoulder system 04.01.0155 glenoid baseplate - ø27x25 (k170452) reverse shoulder system 04.01.0173 glenosphere - ø39x27 (k170452) 2x reverse shoulder system 04.01.0162 glenoid polyaxial locking screw - l34 (k170452) 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 7 months after primary, the patient has been revised due to infection.Surgery completed successfully.All shoulder devices revised.
Additional Manufacturer Narrative
Batch review performed on 20-may-2025 15 items manufactured and released on 12-oct-2020.Expiration date: 01-oct-2025.No anomalies found related to the problem.To date, 12 items of the same lot have been sold with no similar reported event during the period of review.Other devices involved reverse shoulder system 04.01.0110 humeral reverse metaphysis +0mm/0° (k170452) lot.2240211.Batch review performed on 20-may-2025.(b)(4) items manufactured and released on 28-feb-2023.Expiration date: 07-feb-2028.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0122 humeral reverse hc liner ø39/+0mm (k170452) lot.2243888 batch review performed on 20-may-2025 90 items manufactured and released on 06-feb-2023.Expiration date: 22-jan-2028.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0155 glenoid baseplate - ø27x25 (k170452) lot 2242350 batch review performed on 20-may-2025 (b)(4) items manufactured and released on 13-mar-2023.Expiration date: 22-feb-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 04.01.0173 glenosphere - ø39x27 (k170452) lot 2242330 batch review performed on 20-may-2025 (b)(4) items manufactured and released on 09-dec-2022.Expiration date: 24-nov-2027.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.2x reverse shoulder system 04.01.0162 glenoid polyaxial locking screw - l34 (k170452) lot 2244675 batch review performed on 20-may-2025 (b)(4) items manufactured and released on 16-dec-2022.Expiration date: 01-dec-2027.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.The two screws are involved in this case.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: REVERSE SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 14
• 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: 21974457
• Report Number: 3005180920-2025-00381
• Device Sequence Number: 15281383
• Product Code: KWS
• UDI-Device Identifier: 07630040715959
• UDI-Public: 07630040715959
• 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: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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: 10/01/2025
• Device Model Number: 04.01.0187
• Device Lot Number: 2006575
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2020
• 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 Age: 76 YR
• Patient Sex: Male