MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/14MM

Model Number	02.07.0414SCF
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 02 september 2020: lot 173103: (b)(4) items manufactured and released on 28-jul-2017.Expiration date: 2022-07-13.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 had a primary knee surgery on (b)(6) 2018.On (b)(6) 2019, the patient came in due to signs of infection and the pathogen is unknown.The surgeon revised the femoral component and the full-pe ps tibial component and the surgery was completed successfully.Presently, on (b)(6) 2020, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed an i&d and revised the poly.The surgery was completed successfully.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/14MM
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10501586
• Report Number: 3005180920-2020-00567
• Device Sequence Number: 2757386
• Product Code: JWH
• UDI-Device Identifier: 07630030817878
• UDI-Public: 07630030817878
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/13/2022
• Device Model Number: 02.07.0414SCF
• Device Catalogue Number: 02.07.0414SCF
• Device Lot Number: 173103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 09/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention