MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM GLENOSPHERE 39X24.5; SHOULDER PROSTHESIS GLENOSPHERE

Model Number	04.01.0170
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2021: lot 2001809: 43 items manufactured and released on (b)(6) 2020.Expiration date: 2025-07-10.No anomalies found related to the problem.To date, 29 items of the same lot have been already sold without any other similar reported event another device involved: batch review performed on (b)(6) 2021: reverse shoulder system 04.01.0124 humeral reverse hc liner ø39/+6mm (k170452)lot.175050: 52 items manufactured and released on (b)(6) 2017.Expiration date: 2022-09-07.No anomalies found related to the problem.To date, 33 items of the same lot have been already sold with two other similar reported events.
Event or Problem Description
The patient came in reporting pain 1 month after the primary surgery.X-rays indicated that the patient had a dislocation of the glenosphere from the liner.The surgeon placed the patient under anesthesia and reduced the shoulder, and the shoulder seemed stable afterward.

• Brand Name: REVERSE SHOULDER SYSTEM GLENOSPHERE 39X24.5
• Common Device Name: SHOULDER PROSTHESIS GLENOSPHERE
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11462145
• Report Number: 3005180920-2021-00185
• Device Sequence Number: 14500622
• Product Code: PHX
• UDI-Device Identifier: 07630040706575
• UDI-Public: 07630040706575
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 03/11/2021

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: 02/09/2021
• Initial Report FDA Received Date: 03/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention