MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL HC LINER Ø42/+0MM; REVERSE SHOULDER HC LINER

Model Number	04.01.0125
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 april 2022: lot 2001996: (b)(4).Expiration date: 2025-05-06.No anomalies found related to the problem.(b)(4).Additional item involved in the event, batch review performed on 06 april 2022.Reverse shoulder system 04.01.0171 glenosphere 42xø24.5 (k170452) lot.174732 lot 174732: (b)(4).Expiration date: 2022-10-12.No anomalies found related to the problem.(b)(4).
Event or Problem Description
The patient came in reporting pain due to a dislocation of the liner for the glenosphere.The cause of the dislocation is unknown.The surgeon revised the glenosphere, liner, and metaphysis.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL HC LINER Ø42/+0MM
• Common Device Name: REVERSE SHOULDER HC LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; CH 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14247701
• Report Number: 3005180920-2022-00305
• Device Sequence Number: 14645979
• Product Code: PHX
• UDI-Device Identifier: 07630040706322
• UDI-Public: 07630040706322
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2022

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: 05/06/2025
• Device Model Number: 04.01.0125
• Device Catalogue Number: 04.01.0125
• Device Lot Number: 2001996
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2020
• 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