MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; REVERSE SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 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
At about 3 months from primary, the patient has undergone revision due to infection.The surgeon revised all components successfully.
Additional Manufacturer Narrative
Lot are not available at the moment and it is not possible to perform batch review.Additional implants 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).Reverse shoulder system 04.01.0161 glenoid polyaxial locking screw - l30 (k170452).Reverse shoulder system 04.01.0161 glenoid polyaxial locking screw - l30 (k170452).Infection is a known possible complication of any surgery.
Additional Manufacturer Narrative
Upon receiving information on the lots of the devices involved in this event it was noticed that the event had already been reported in a previous complaint.Therefore, the present report, mdr 2025-00392, is a duplicate of report mdr 2025-00100 submitted on 11 february 2025.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: REVERSE SHOULDER SYSTEM SHORT HUMERAL DIAPHYSIS - CEMENTLESS - 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: 21974540
• Report Number: 3005180920-2025-00392
• Device Sequence Number: 7227743
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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