MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+6MM; SHOULDER REVERSE LINER

Catalog Number	04.01.0121
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary (b)(6) 2019.On (b)(6) 2024, the patient came in reporting pain due to a loose glenoid component.The cause of the loose glenoid component is unknown.The surgeon revised the glenoid, glenosphere, metaphysis and liner.The surgery was completed successfully.Presently, on (b)(6) 2024, the patient came in reporting pain due to a dislocation of the liner from the glenosphere.The surgeon revised the baseplate, glenosphere, screws, metaphysis and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 26 aug 2024.Lot 2312095: (b)(4) items manufactured and released on 05-sept-2023.Expiration date: 2028-08-22.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 component involved in the event: batch review performed on 26 aug 2024 reverse shoulder system 04.01.0169 glenosphere - ø36x24.5 (k170452) lot 2318832: (b)(4) items manufactured and released on 13-dec-2023.Expiration date: 2028-11-25.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/+6MM
• Common Device Name: SHOULDER REVERSE 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: 20237365
• Report Number: 3005180920-2024-00734
• Device Sequence Number: 15494696
• Product Code: PHX
• UDI-Device Identifier: 07630040706285
• UDI-Public: 07630040706285
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 09/17/2024

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: 04.01.0121
• Device Lot Number: 2312095
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/05/2023
• 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 Age: 62 YR
• Patient Sex: Female