MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM 04.01.0209 LAT. GLENOSPHERE 42XØ24.5; SHOULDER LAT. GLENOSPHERE

Model Number	04.01.0209
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	04/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary shoulder surgery on (b)(6) 2023.On (b)(6) 2023, the patient came in reporting instability and the cause was unknown.The surgeon revised the insert and the surgery was completed successfully.On (b)(6) 2023, the patient came reporting pain due to a dislocation of the liner from the glenosphere and the cause was unknown.The surgeon revised the liner and glenosphere and the surgery was completed successfully.Presently, on (b)(6) 2023, the patient came reporting pain due to a dislocation of the liner from the glenosphere and the cause is unknown.The surgeon revised the liner, glenosphere, and metaphysis.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023: lot 2103688: (b)(4) items manufactured and released on 28-may-2021.Expiration date: 2026-05-.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event in the period of review.Other devices involved: reverse shoulder system 04.01.0125 humeral reverse hc liner ø42/+0mm (k170452) lot 2218471: (b)(4) items manufactured and released on 30-sep-2022.Expiration date: 2027-09-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event in the period of review.

• Brand Name: REVERSE SHOULDER SYSTEM 04.01.0209 LAT. GLENOSPHERE 42XØ24.5
• Common Device Name: SHOULDER LAT. 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: 16859024
• Report Number: 3005180920-2023-00297
• Device Sequence Number: 6526582
• Product Code: HSD
• UDI-Device Identifier: 07630040728089
• UDI-Public: 07630040728089
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K193175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 05/03/2023

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: 05/31/2026
• Device Model Number: 04.01.0209
• Device Catalogue Number: 04.01.0209
• Device Lot Number: 2103688
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2021
• 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: Unknown