MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; LAT. GLENOSPHERE 36XØ24.5

Model Number	04.01.0207
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During a clinical study, the patient had a coracoid fracture due to excessive lateralization of the prosthesis during implantation.The patient is undergoing physiotherapy.
Additional Manufacturer Narrative
Batch review performed on 29-jan-2025.(b)(4) items manufactured and released on 27-sep-2023.Expiration date: 07-sep-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.Additional implants also revised: reverse shoulder system 04.01.0119 humeral reverse hc liner ø36/+0mm (k170452) lot: 2245561 (b)(4) items manufactured and released on 13-apr-2023.Expiration date: 20-mar-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.Batch review for reverse shoulder system 04.01.0152 glenoid baseplate - ø24.5x25 (k170452) lot: 2249370.(b)(4) items manufactured and released on 03-may-2023.Expiration date: 16-apr-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.Clinical evaluation performed by clinical affairs department: 1 year after the primary rsa surgery, the patient had a coracoid fracture.According to report, this happened due to excessive lateralization of the prosthesis during implantation.No revision surgery is planned.With only this radiographic image and this piece of information it is not possible to infer the cause of the event.However, with the information at hand there is not reason to suspect a malfunctioning device.
Additional Manufacturer Narrative
Follow up 1: - description event updated.
Event or Problem Description
During a clinical study, the patient had a coracoid fracture due to excessive lateralization of the prosthesis during implantation.The patient is undergoing physiotherapy and it is under surveillance.It has been reported that my shoulder was used in the primary.Bone quality is precarious.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: LAT. GLENOSPHERE 36XØ24.5
• 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: 21354818
• Report Number: 3005180920-2025-00078
• Device Sequence Number: 8959796
• Product Code: HSD
• UDI-Device Identifier: 07630040728065
• UDI-Public: 07630040728065
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K193175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 03/07/2025

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: 04.01.0207
• Device Lot Number: 2313375
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2023
• 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: Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 52 KG