MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE FIXED TIBIAL INSERT SIZE 3/17MM

Model Number	01.32.3248HCT
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 october 2020: lot 155452: (b)(4) items manufactured and released on 25 may-2018.Expiration date: 24-apr-2023.No anomalies found related to the problem.To date, 14 items of the same lot have been sold without 1 similar reported event.
Event or Problem Description
1 month after previous revision surgery, the patient came in due to signs of infection and the pathogen is unknown.The surgeon performed a washout and poly-swap and the surgery was completed successfully.Previously the patient had revised al components due to subsidence of the tibial component on (b)(6) 2020.On (b)(6) 2018 the patient had an infection and liner revision.

• Brand Name: GMK-HINGE FIXED TIBIAL INSERT SIZE 3/17MM
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10852298
• Report Number: 3005180920-2020-00801
• Device Sequence Number: 641120
• Product Code: KRO
• UDI-Device Identifier: 07630030811951
• UDI-Public: 07630030811951
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K130299
• 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: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/17/2020

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: 04/24/2023
• Device Model Number: 01.32.3248HCT
• Device Catalogue Number: 02.09.0317H
• Device Lot Number: 181582
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 11/17/2020
• 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