MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+3MM; SHOULDER REVERSE SYSTEM HIGH-CROSS LINER

Catalog Number	04.01.0120
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary shoulder surgery on (b)(6) 2022.On (b)(6) 2023, the patient had a shoulder hemi-arthroplasty surgery on (b)(6) 2022.On (b)(6) 2023, the patient came in reporting pain after falling and the cause is unknown.The surgeon revised the patient to a reverse shoulder and the surgery was completed successfully.On (b)(6) 2023, the patient came in reporting pain due to a dislocation of the liner from the glenosphere and the cause is unknown.The surgeon revised the metaphysis and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 03-aug-2023 lot 2112129: (b)(4) items manufactured and released on 11-oct-2021.Expiration date: 2026-09-21.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.Additional involved implant: batch review performed on (b)(6) 2023 on reverse shoulder system 04.01.0207; lat.Glenosphere 36xø24.5 (k193175); lot.2246186.Lot 2246186: (b)(4) items manufactured and released on 08-feb-2023.Expiration date: 2028-01-23.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 HUMERAL REVERSE HC LINER Ø36/+3MM
• Common Device Name: SHOULDER REVERSE SYSTEM HIGH-CROSS LINER
• 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: 17489203
• Report Number: 3005180920-2023-00648
• Device Sequence Number: 7872432
• Product Code: PHX
• UDI-Device Identifier: 07630040706278
• UDI-Public: 07630040706278
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170452
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2023

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: 09/21/2026
• Device Catalogue Number: 04.01.0120
• Device Lot Number: 2112129
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2023
• Initial Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2021
• 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: Female