MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM 04.01.0124 HUMERAL REVERSE HC LINER Ø39/+6MM; SHOULDER HUMERAL REVERSE HC LINER

Catalog Number	04.01.0124
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 10 october 2023: lot 2212977: (b)(4) items manufactured and released on 06-sep-2022.Expiration date: 2027-08-16.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.Other devices involved: batch review performed on 10 october 2023: lot 2247046: (b)(4) items manufactured and released on 23-feb-2023.Expiration date: 2028-02-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 2 other similar reported events in the period of review, one of them is on the same implant that was not revised in a precedent surgery on the same patient.
Event or Problem Description
The patient had a primary shoulder surgery on (b)(6) 2023.On (b)(6) 2023, the patient came in reporting pain due to a dislocation of the liner from the glenosphere.The cause of the dislocation is unknown.The surgeon revised the liner and the surgery was completed successfully.On (b)(6) 2023, the patient had a dislocation of the liner from the glenosphere.The surgeon revised the glenosphere, liner, and metaphysis.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM 04.01.0124 HUMERAL REVERSE HC LINER Ø39/+6MM
• Common Device Name: SHOULDER HUMERAL REVERSE HC 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: 18055001
• Report Number: 3005180920-2023-00844
• Device Sequence Number: 15208253
• Product Code: PHX
• UDI-Device Identifier: 07630040706315
• UDI-Public: 07630040706315
• 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): 11/02/2023

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 Catalogue Number: 04.01.0124
• Device Lot Number: 2212977
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2022
• 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