MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ24.5; SHOULDER PROSHESIS GLENOSPHERE

Model Number	04.01.0170
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
At 9 months and half after the primary, the patient came in reporting instability and the cause of instability is unknown.The surgeon revised the liner and glenosphere and the surgery was completed successfully.The surgeon revised the glenosphere because he wanted to lateralize the component.
Additional Manufacturer Narrative
Batch review performed on 01 december 2021: lot 2001809: (b)(4) items manufactured and released on 20-july-2020.Expiration date: 2025-07-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Other device involved: batch review performed on 01 december 2021: reverse shoulder system 04.01.0124 humeral reverse hc liner ø39/+6mm (k170452) lot 1810828: (b)(4) items manufactured and released on 22-feb-2019.Expiration date: 2024-02-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 39XØ24.5
• Common Device Name: SHOULDER PROSHESIS GLENOSPHERE
• 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: 13001581
• Report Number: 3005180920-2021-01005
• Device Sequence Number: 14631424
• Product Code: PHX
• UDI-Device Identifier: 07630040706575
• UDI-Public: 07630040706575
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2021

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 Expiration Date: 07/10/2025
• Device Model Number: 04.01.0170
• Device Catalogue Number: 04.01.0170
• Device Lot Number: 2001809
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2020
• 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: Male