MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/20MM

Model Number	02.07.0320SCF
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 november 2020: lot 134143: 12 items manufactured and released on 03-dec-2013.Expiration date: 2018-10-31.No anomalies found related to the problem.To date, 10 items of the same lot have been already sold without any similar reported event since 1-1-2016.
Event or Problem Description
Revision surgery for knee infection about 4 years after device implantation.Low-grade infection, the pathogen is unknown.The surgeon performed knee debridement and liner swap successfully.

• Brand Name: GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/20MM
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10895746
• Report Number: 3005180920-2020-00838
• Device Sequence Number: 19640562
• Product Code: JWH
• UDI-Device Identifier: 07630030817519
• UDI-Public: 07630030817519
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/24/2020

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: 10/31/2018
• Device Model Number: 02.07.0320SCF
• Device Catalogue Number: 02.07.0320SCF
• Device Lot Number: 134143
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 11/24/2020
• 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: 60 YR
• Patient Weight: 95