MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/10MM; KNEE TIBIAL INSERT

Model Number	02.07.0410SCF
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	08/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25 august 2021: lot 154250: (b)(4) items manufactured and released on 25-nov-2015.Expiration date: 2020-nov-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event since 2017.
Event or Problem Description
The patient came in reporting knee pain and instability and the cause of the pain and instability is unknown.1 year and 7 months after the primary surgery, 02.07.0410scf insert semiconstrained 10mm s4 154250 was explanted and a 02.07.0414scf insert semiconstrained 14mm s4 1908935 was implanted.The surgery was completed successfully.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/10MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12473080
• Report Number: 3005180920-2021-00734
• Device Sequence Number: 17088715
• Product Code: JWH
• UDI-Device Identifier: 07630030817656
• UDI-Public: 07630030817656
• 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: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2021

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: 11/07/2020
• Device Model Number: 02.07.0410SCF
• Device Catalogue Number: 02.07.0410SCF
• Device Lot Number: 154250
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 09/15/2021
• 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