MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 6/10MM; KNEE TIBIAL INSERT

Model Number	02.07.0610SCF
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in due to signs of an infection, 2 months after the primary surgery, the pathogen is unknown.The surgeon performed a washout and revised the poly and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2022 lot 188130: 25 items manufactured and released on 21-nov-2018.Expiration date: 2023-11-06.No anomalies found related to the problem.To date, 1 item of the same lot have been sold.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 6/10MM
• Common Device Name: KNEE 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: 14840407
• Report Number: 3005180920-2022-00498
• Device Sequence Number: 2367588
• Product Code: JWH
• UDI-Device Identifier: 07630030818813
• UDI-Public: 07630030818813
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 06/28/2022

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: 11/06/2023
• Device Model Number: 02.07.0610SCF
• Device Catalogue Number: 02.07.0610SCF
• Device Lot Number: 188130
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2018
• 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