MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/17MM; TIBIAL INSERT FIXED

Model Number	02.07.0217SCF
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 november 2020: lot 188126: (b)(4) items manufactured and released on 21-nov-2018.Expiration date: 2023-11-05.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 2016.Clinical evaluation 6 months after revision tka anterior knee pain causes further revision, also because the patellar component was still from another manufacturer, along with ligament adjustments.The patella is exchanged and, as customary, the insert is also exchanged, for precautionary measure.No reason to suspect a faulty device.
Event or Problem Description
6 months after revision surgery (competitor products were revised and medacta gmk revision implanted) the patient returned due to anterior knee pain and patellar mal tracking.Revision surgery was performed with liner exchange and patellar component exchange and lateral release of the patellar ligament (previously to this surgery the patella inside was from another manufacturer).

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/17MM
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10959279
• Report Number: 3005180920-2020-00870
• Device Sequence Number: 14058219
• Product Code: JWH
• UDI-Device Identifier: 07630030816833
• UDI-Public: 07630030816833
• Combination Product (Y/N): Y
• Initial Reporter Country: IS
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/05/2023
• Device Model Number: 02.07.0217SCF
• Device Catalogue Number: 02.07.0217SCF
• Device Lot Number: 188126
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2020
• Initial Report FDA Received Date: 12/07/2020
• 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
• Patient Age: 68 YR
• Patient Weight: 68