MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 6/17MM; TIBIAL INSERT FIXED

Model Number	02.07.0617SCF
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20-oct-2020.Lot 156523: (b)(4) items manufactured and released on 23-nov-2015.Expiration date: 25-oct-2020.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 since 2016.
Event or Problem Description
The patient came in due to signs of infection 24 days after primary surgery, the pathogen is unknown.The surgeon performed a washout and poly-swap and the surgery was completed successfully.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 6/17MM
• Common Device Name: TIBIAL INSERT FIXED
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10710631
• Report Number: 3005180920-2020-00737
• Device Sequence Number: 17070975
• Product Code: JWH
• UDI-Device Identifier: 07630030819155
• UDI-Public: 07630030819155
• 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: 2020
• Device Explanted Year: 2020
• 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): 10/21/2020

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: 10/25/2020
• Device Model Number: 02.07.0617SCF
• Device Catalogue Number: 02.07.0617SCF
• Device Lot Number: 156523
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 10/21/2020
• 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