MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/20MM; KNEE TIBIAL INSERT

Model Number	02.07.0220SCF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	06/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2022.On (b)(6) 2022, the patient came in reporting pain due to a fractured tibia and the cause is unknown.The surgeon revised the tibial tray and insert.The surgery was completed successfully.Presently, on (b)(6) 2023, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the femur and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 04-jul-2023.Lot 2118827: (b)(4) items manufactured and released on 23-feb-2022.Expiration date: 2027-01-31.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Additional component involved in the event: gmk-revision 02.07.2403r femur revision ps size 3 r (k102437) lot 2118575: (b)(4) items manufactured and released on 26-apr-2022.Expiration date: 2027-04-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/20MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17276837
• Report Number: 3005180920-2023-00506
• Device Sequence Number: 17027880
• Product Code: JWH
• UDI-Device Identifier: 07630030816932
• UDI-Public: 07630030816932
• 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: 2022
• Device Explanted Year: 2023
• 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): 07/07/2023

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 Model Number: 02.07.0220SCF
• Device Catalogue Number: 02.07.0220SCF
• Device Lot Number: 2118827
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2023
• Initial Report FDA Received Date: 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2022
• 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: Female