MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/20MM; TIBIAL INSERT FIXED

Model Number	02.07.0420SCF
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 august 2021: lot 1906430: (b)(4) items manufactured and released on 03-sep-2019.Expiration date: 2024-08-19.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.Additional items involved in the event, batch review performed on 01 august 2021: gmk-revision 02.07.2405r femur revision ps size 5 r lot.167068: lot 167068: (b)(4) items manufactured and released on 11-jan-2017.Expiration date: 2021-12-18.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Gmk-revision 02.07.Fcl13065 extension stem - fluted ø 13 l 65 lot.115703a: lot 115703a: (b)(4) items manufactured and released on 09-nov-2017.Expiration date: 2022-10-16.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Gmk-revision 02.07.0005 offset connector 5 mm lot.1909719: lot 1909719: (b)(4) items manufactured and released on 19-feb-2020.Expiration date: 2025-02-04.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.Gmk-revision 02.07.1204r fixed tibial tray cemented size 4 r lot.111454: lot 111454: (b)(4) items manufactured and released on 17-jun-2011.Expiration date: 2016-04-30.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 since 2017.
Event or Problem Description
The patient had primary knee surgery on (b)(6) 2012 and had the total knee implanted around a nail.On (b)(6) 2021, the surgeon removed the femoral component and poly to remove the nail.On (b)(6) 2021, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the poly.Presently, on (b)(6) 2021, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all implants, and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/20MM
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12370172
• Report Number: 3005180920-2021-00676
• Device Sequence Number: 19824566
• Product Code: JWH
• UDI-Device Identifier: 07630030818097
• UDI-Public: 07630030818097
• 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: 2021
• Device Explanted Year: 2021
• 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): 08/26/2021

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: 08/19/2024
• Device Model Number: 02.07.0420SCF
• Device Catalogue Number: 02.07.0420SCF
• Device Lot Number: 1906430
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/26/2021
• 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