MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 4/17MM

Model Number 02.09.0417H

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Date 07/27/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed by medacta regulatory affairs department on 07.08.2020: lot 189417: (b)(4) items manufactured and released on 12-feb-2019.Expiration date: 2024-jan-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.

Event Description

The patient came in 2 months after the primary surgery due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the liner.The surgery was completed successfully.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 4/17MM
• Type of Device: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 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: 10447978
• MDR Text Key: 204341580
• Report Number: 3005180920-2020-00541
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07630030825217
• UDI-Public: 07630030825217
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130299
• 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: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2024
• Device Model Number: 02.09.0417H
• Device Catalogue Number: 02.09.0417H
• Device Lot Number: 189417
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/12/2019
• 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