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

Model Number	04.01.0151
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30-may-2023 lot 2244719: 50 items manufactured and released on 05-apr-2023.Expiration date: 2028-03-16.No anomalies found related to the problem.To date, 25 items of the same lot have been sold without any similar reported event during the period of review.Additional involved implant: batch review performed on 30-may-2023 on reverse shoulder system 04.01.0169 glenosphere 36xø24.5 (k170452) lot.2247038 lot 2247038: 100 items manufactured and released on 17-feb-2023.Expiration date: 2028-01-31.No anomalies found related to the problem.To date, 25 items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
The glenoid bone fractured during the glenosphere thightening.Rsa implants were immediately revised with an hsa.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOID BASEPLATE Ø24.5X15
• Common Device Name: SHOULDER REVERSE GLENOID BASEPLATE
• 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: 17077623
• Report Number: 3005180920-2023-00415
• Device Sequence Number: 11315887
• Product Code: PHX
• UDI-Device Identifier: 07630040706384
• UDI-Public: 07630040706384
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/07/2023

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 Catalogue Number: 04.01.0151
• Device Lot Number: 2244719
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/05/2023
• 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: Required Intervention
• Patient Sex: Unknown