MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE UC FIXED TIBIAL INSERT SIZE 4/14MM; FIXED TIBIAL INSERT ULTRA CONGRUENT

Model Number	02.09.0414UCH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 march 2022.Lot 183642: (b)(4) items manufactured and released on 21-aug-2018.Expiration date: 2023-07-25.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the poly 1 year and 9 months after primary.The surgery was completed successfully.

• Brand Name: GMK-HINGE UC FIXED TIBIAL INSERT SIZE 4/14MM
• Common Device Name: FIXED TIBIAL INSERT ULTRA CONGRUENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; CH 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: 14159949
• Report Number: 3005180920-2022-00261
• Device Sequence Number: 2945486
• Product Code: KRO
• UDI-Device Identifier: 07630030879340
• UDI-Public: 07630030879340
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172347
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/20/2022

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: 07/25/2023
• Device Model Number: 02.09.0414UCH
• Device Catalogue Number: 02.09.0414UCH
• Device Lot Number: 183642
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2018
• 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: Unknown