MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/14MM

Model Number	02.07.0314SCF
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	07/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2019.On (b)(6) 2022, the patient came in reporting pain due to loose implants and the cause is unknown.The surgeon revised all components and the surgery was completed successfully.Presently, on (b)(6) 2022, the patient came in reporting stiffness and the cause is unknown.The surgeon revised the insert semiconstrained 14mm s3 with an insert semiconstrained 10mm s3.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 17-august-2022.Lot 180467: (b)(4) items manufactured and released on 25-apr-2018.Expiration date: 2023-04-15.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 3/14MM
• 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: 15240571
• Report Number: 3005180920-2022-00616
• Device Sequence Number: 11926162
• Product Code: JWH
• UDI-Device Identifier: 07630030817298
• UDI-Public: 07630030817298
• 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): 08/17/2022

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: 04/15/2023
• Device Model Number: 02.07.0314SCF
• Device Catalogue Number: 02.07.0314SCF
• Device Lot Number: 180467
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2018
• 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: Female