MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X30; SHOULDER REVERSE GLENOID BASEPLATE

Model Number	04.01.0191
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11 april 2023.Lot 1904749: (b)(4) items manufactured and released on 04-dec-2019.Expiration date: 2024-nov-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.Clinical evaluation performed by medical affairs department: revision 1 year and 7 months after the primary rsa surgery, due to a malpositioned baseplate and glenosphere ( the block was found tilted superiorly).The causes for this event cannot be determined with certainty with the elements at hand.This may have happened due to an impingement of the humeral stem with the baseplate which may have caused the movement of the baseplate and malpositioning of the glenoidal implant.If the metaphysis is malpositioned, it could pry up the glenosphere with the baseplate attached.Additional involved implant: batch review performed on 11 april 2023 on reverse shoulder system 04.01.0207 lat.Glenosphere 36xø24.5 (k193175) lot.2005600 lot 2005600: (b)(4) items manufactured and released on 05-oct-2020.Expiration date: 2025-sep-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.
Event or Problem Description
The patient came in reporting pain due to a malpositioned baseplate and glenosphere (tilted superior) and the cause is unknown.About 1 year and 7 months after the primary surgery, the surgeon revised the medacta metaphysis, baseplate, screws and glenosphere.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM THREADED GLENOID BASEPLATE Ø24.5X30
• Common Device Name: SHOULDER REVERSE GLENOID BASEPLATE
• 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: 16874674
• Report Number: 3005180920-2023-00300
• Device Sequence Number: 5830082
• Product Code: PHX
• UDI-Device Identifier: 07630040715478
• UDI-Public: 07630040715478
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K171058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• 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): 05/05/2023

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: 11/24/2024
• Device Model Number: 04.01.0191
• Device Catalogue Number: 04.01.0191
• Device Lot Number: 1904749
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2023
• Initial Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2019
• 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