MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/12MM; KNEE FIXED TIBIAL INSERT

Model Number	02.07.0312SCF
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	03/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 april 2022.Lot 187612: (b)(4) items manufactured and released on 13-nov-2018.Expiration date: 2023-10-29.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
The patient was implanted with competitor knee components.On (b)(6) 2021, the patient had the competitor components removed due to an infection and the surgeon implanted an insert and femoral component as a spacer.The surgery was completed successfully.On (b)(6) 2022 the patient had the spacer removed and the surgeon revised the patient with all new medacta hardware.The surgery was completed successfully.Presently, on (b)(6) 2022 the patient came in reporting tightness in the knee and the cause of the tightness is unknown.The surgeon revised the liner (20 mm to 10 mm) and the surgery was completed successfully.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/12MM
• Common Device Name: KNEE 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: 13975654
• Report Number: 3005180920-2022-00217
• Device Sequence Number: 17344666
• Product Code: JWH
• UDI-Device Identifier: 07630030817175
• UDI-Public: 07630030817175
• 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: 2022
• 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): 04/01/2022

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: 10/29/2023
• Device Model Number: 02.07.0312SCF
• Device Catalogue Number: 02.07.0312SCF
• Device Lot Number: 187612
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2018
• 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