MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/12MM; TIBIAL INSERT FIXED

Model Number	02.07.0412SCF
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 2 june 2021: lot 173102: (b)(4) items manufactured and released on 29-nov-2017.Expiration date: 2022-11-05.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation: 4th operation on a patient with tka caused by infection.Only the tibial insert was replaced, becasue the surgeon assessed that the metal components were well fixed and there was no infection at the interface.The cause for this reoperation is not to be sought in a defective implant.
Event or Problem Description
Revision surgery performed 2 years 3 months after the previous surgery due to signs of infection.Tibial insert successfully revised.This is the 4th operation on a patient with tka and the first surgery caused by infection.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/12MM
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12067155
• Report Number: 3005180920-2021-00518
• Device Sequence Number: 17228856
• Product Code: JWH
• UDI-Device Identifier: 07630030817755
• UDI-Public: 07630030817755
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 06/25/2021

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: 11/05/2022
• Device Model Number: 02.07.0412SCF
• Device Catalogue Number: 02.07.0412SCF
• Device Lot Number: 173102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 06/25/2021
• 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
• Patient Age: 54 YR
• Patient Weight: 100