MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM 04.01.0208 LAT. GLENOSPHERE 39XØ24.5; SHOULDER GLENOSPHERE

Model Number	04.01.0208
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	03/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary shoulder surgery on (b)(6) 2022.On (b)(6) 2022, the patient came in reporting instability and the cause of the instability is unknown.The surgeon revised successfully the insert.Presently, on (b)(6) 2023, the patient came in reporting pain due to a dislocation of the liner from the glenosphere.The surgeon revised successfully the liner and glenosphere.
Additional Manufacturer Narrative
Batch review performed on 11-apr-2023: lot 2103687: (b)(4) manufactured and released on 13-jul-2021.Expiration date: 2026-06-24.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported case during the period of review.Other device involved: batch review performed on 11-apr-2023 reverse shoulder system 04.01.0124 humeral reverse hc liner ø39/+6mm (k170452) lot 2006595: (b)(4) manufactured and released on 29-oct-2020.Expiration date: 2025-10-20.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported case during the period of review.

• Brand Name: REVERSE SHOULDER SYSTEM 04.01.0208 LAT. GLENOSPHERE 39XØ24.5
• Common Device Name: SHOULDER GLENOSPHERE
• 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: 16722683
• Report Number: 3005180920-2023-00255
• Device Sequence Number: 7293281
• Product Code: HSD
• UDI-Device Identifier: 07630040728072
• UDI-Public: 07630040728072
• 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: 2022
• Device Explanted Year: 2023
• 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): 04/12/2023

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 Expiration Date: 06/24/2026
• Device Model Number: 04.01.0208
• Device Catalogue Number: 04.01.0208
• Device Lot Number: 2103687
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2021
• 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 Sex: Male