MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 1/20MM

Model Number 02.09.0120H

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 11/13/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 25 november 2020 lot 161838: (b)(4) items manufactured and released on 12-apr-2016.Expiration date: 28.Mar.2021.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

Washout out and ploy swap almost 2 months after primary since the wound did not heal.Infection was confirmed, the pathogen was strep oralis and strep mitis.The surgery was completed successfully.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 1/20MM
• 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: 10974217
• MDR Text Key: 220401365
• Report Number: 3005180920-2020-00884
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 07630030825019
• UDI-Public: 07630030825019
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/09/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2021
• Device Model Number: 02.09.0120H
• Device Catalogue Number: 02.09.0120H
• Device Lot Number: 161838
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 12/09/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/12/2016
• 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