MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-HINGE UC FIXED TIBIAL INSERT SIZE 2/20MM

Model Number	02.09.0220UCH
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 08 september 2020: lot 183630: (b)(4) items manufactured and released on 21-ago-2018.Expiration date: 2023-07-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2020 in which competitor products were removed and the surgeon implanted a gmk-hinge spacer with antibiotic cement to act as a spacer.On (b)(6) 2020, the surgeon removed the gmk-hinge spacer and implanted permanent medacta hardware.On (b)(6) 2020 (about 3 months after primary), the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and the surgery was completed successfully.No product was revised.Presently, on (b)(6) 2020 (2 days after first revision surgery) the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout and revised the liner.The surgery was completed successfully.

• Brand Name: GMK-HINGE UC FIXED TIBIAL INSERT SIZE 2/20MM
• Common Device Name: FIXED TIBIAL INSERT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10586666
• Report Number: 3005180920-2020-00641
• Device Sequence Number: 1257680
• Product Code: KRO
• UDI-Device Identifier: 07630030879227
• UDI-Public: 07630030879227
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K172347
• 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: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2020

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: 07/24/2023
• Device Model Number: 02.09.0220UCH
• Device Catalogue Number: 02.09.0220UCH
• Device Lot Number: 183630
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 09/25/2020
• 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