MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 32XØ24.5; REVERSE SHOULDER GLENOSPHERE

Model Number	04.01.0206
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	02/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At 10 months after the primary surgery, the surgeon revised the glenosphere and liner due to instability.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 22 february 2022.Lot 1811033: (b)(4) items manufactured and released on 27-mar-2019.Expiration date: 2024-03-18.No anomalies found related to the problem.To date, (b)(4) items of the same lot has been sold without any similar reported event.Additional component involved: reverse shoulder system 04.01.0118 humeral reverse hc liner ø32/+6mm (k170452) lot 173416: (b)(4) items manufactured and released on 27-june-2017.Expiration date: 2022-06-08.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 LAT. GLENOSPHERE 32XØ24.5
• Common Device Name: REVERSE SHOULDER 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: 13770429
• Report Number: 3005180920-2022-00173
• Device Sequence Number: 3822702
• Product Code: HSD
• UDI-Device Identifier: 07630040728058
• UDI-Public: 07630040728058
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K193175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 03/15/2022

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 Expiration Date: 03/18/2024
• Device Model Number: 04.01.0206
• Device Catalogue Number: 04.01.0206
• Device Lot Number: 1811033
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2019
• 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: Female