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

Catalog Number 04.01.0121

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problem Unspecified Infection (1930)

Event Date 10/30/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 10-nov-2023: lot 2109615: 27 items manufactured and released on 11-oct-2021.Expiration date: 2026-09-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of the review.

Event Description

At about 1 year and 2 months after primary, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised successfully the liner.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE HC LINER Ø36/+6MM
• Type of Device: 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: 18237289
• MDR Text Key: 329369563
• Report Number: 3005180920-2023-00930
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 07630040706285
• UDI-Public: 07630040706285
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.01.0121
• Device Lot Number: 2109615
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female