MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; REVERSE SHOULDER SYSTEM 04.01.0151 GLENOID BASEPLATE - Ø24.5X15

Model Number	04.01.0151
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During the shoulder surgery, during the insertion of the trial liner and after implantation of stem and metaphysis, it was noticed a fracture of the glenoid bone.The cause is unknown, even if an hypothesis is that the fracture could occur when the reduction was done using the implant and the trial stem, or when the stem implant was put in and the trial liner was attached.The already implanted baseplate (ø24.5x15) was replaced to a 27mm baseplate and fixed with polyaxial screws in anterior and posterior holes.On the humeral side, diaphysis, reverse metaphysis and liner were placed.The glenosphere was removed and new glenosphere was not inserted.After bone union about 3 to 6 months, new glenosphere will be implanted.The surgery was completed successfully.The total surgery time was 2 hours and 10 minutes.The delay time was 30 minutes.The bone quality was slightly poor.
Additional Manufacturer Narrative
Batch review performed on 06-feb-2025: lot 2413517: (b)(4) items manufactured and released on 09-sep-2024.Expiration date: 22-aug-2029.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.Visual inspection: the provided implants do not show any signs of damage.It is not clear when and where the glenoid fracture occurred.The poor bone quality may have contributed to the fracture.The absence of a glenosphere will result in an unstable joint and potentially to friction between the liner or the metaphysis with the glenoid with subsequent risk of pe debris generation or metallosis.There is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Additional Manufacturer Narrative
Clinical evaluation performed by r&d project manager.Without radiographic images, a clinical evaluation cannot be performed.According to the report, it is unclear when the glenoid fracture occurred.However, the report indicates that the bone quality is poor, which may have contributed to the fracture.Without the glenosphere, the joint will be unstable, and friction between the liner or the metaphysis with the baseplate could increase the risk of polyethylene debris generation or metallosis.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: REVERSE SHOULDER SYSTEM 04.01.0151 GLENOID BASEPLATE - Ø24.5X15
• 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: 21446258
• Report Number: 3005180920-2025-00115
• Device Sequence Number: 7874475
• Product Code: PHX
• UDI-Device Identifier: 07630040706384
• UDI-Public: 07630040706384
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/19/2025

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: 04.01.0151
• Device Lot Number: 2413517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2024
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 48 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian