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	Pain (1994)
Date of Event	12/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary shoulder surgery on (b)(6) 2021.On (b)(6) 2021, 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.Presently, on (b)(6) 2022, the patient came in reporting pain due to anterior subluxation of the reverse revision components.The surgeon revised the glenosphere, insert, and metaphysis.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 5 december 2022 lot 2103687: (b)(4) items manufactured and released on 13-jul-2021.Expiration date: 2026-jun-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Other device involved: batch review performed on 5 december 2022.Reverse shoulder system 04.01.0124 humeral reverse hc liner ø39/+6mm lot.2103929 (k170452): (b)(4) items manufactured and released on 28-may-2021.Expiration date: 2026-may-11.No anomalies found related to the problem.To date, (b)(4)items of the same lot have been sold with no similar reported event 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16015095
• Report Number: 3005180920-2022-00950
• Device Sequence Number: 20689512
• Product Code: HSD
• UDI-Device Identifier: 07630040728072
• UDI-Public: 07630040728072
• Combination Product (Y/N): N
• 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): 12/20/2022

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: 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: 12/02/2022
• Initial Report FDA Received Date: 12/20/2022
• 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