MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/17MM

Model Number	02.07.0417SCF
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24 november 2021: lot 1903723: 25 items manufactured and released on 25-jul-2019.Expiration date: 2024-07-09.No anomalies found related to the problem.To date, 9 items of the same lot have been sold without another similar reported event.Additional items involved in the event, batch review performed on 24-nov-2021: gmk-revision 02.07.2405r femur revision ps size 5 r (k102437) lot.174928 lot 174928: 23 items manufactured and released on 11-oct-2017.Expiration date: 2022-09-27.No anomalies found related to the problem.To date, 17 items of the same lot have been sold without any similar reported event.Gmk-revision 02.07.0684r revision fixed tibial tray cemented size 4 r (k123721) lot.1908398 lot 1908398: 10 items manufactured and released on 17-feb-2020.Expiration date: 2025-02-03.No anomalies found related to the problem.To date, 9 items of the same lot have been sold without any similar reported event.
Event or Problem Description
The patient had a primary knee surgery and was implanted with competitor hardware.On (b)(6) 2021, the patient came in and had the competitor hardware revised to medacta hardware for reasons unknown.The surgery was completed successfully.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 and the surgery was completed successfully.On (b)(6), the surgeon performed a washout, removed all components and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/17MM
• Common Device Name: 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: 12983265
• Report Number: 3005180920-2021-00980
• Device Sequence Number: 20247835
• Product Code: JWH
• UDI-Device Identifier: 07630030817991
• UDI-Public: 07630030817991
• 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): 12/13/2021

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: 07/09/2024
• Device Model Number: 02.07.0417SCF
• Device Catalogue Number: 02.07.0417SCF
• Device Lot Number: 1903723
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2019
• 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