MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM 04.01.0152 GLENOID BASEPLATE Ø24.5X25; SHOULDER GLENOID BASEPLATE

Model Number	04.01.0152
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 months after the primary surgery, revision surgery was performed due to a glenoid bone fracture.The cause of this bone fracture is not known.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 07-jun-2022.Lot 2110376: (b)(4) items manufactured and released on 22-nov-2021.Expiration date: 2026-nov-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported case during the period of review.Clinical evaluation performed by medical affairs manager: revision 2 months after primary rsa in a (b)(6) patient due to glenoid fracture.The reason of this event is unknown.No reason to suspect that this event is due to a faulty device.

• Brand Name: REVERSE SHOULDER SYSTEM 04.01.0152 GLENOID BASEPLATE Ø24.5X25
• Common Device Name: SHOULDER GLENOID BASEPLATE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14883694
• Report Number: 3005180920-2022-00503
• Device Sequence Number: 14712334
• Product Code: PHX
• UDI-Device Identifier: 07630040706391
• UDI-Public: 07630040706391
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 07/01/2022

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: 04.01.0152
• Device Catalogue Number: 04.01.0152
• Device Lot Number: 2110376
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2021
• 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: 80 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White