MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FEMUR PS SIZE 4 L; FEMORAL COMPONENT

Model Number	02.07.2404L
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 july 2021: lot 164175: (b)(4) items manufactured and released on 26-aug-2016.Expiration date: 2021-07-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Other devices involved: batch review performed on 05 july 2021: gmk-revision 02.07.0684l revision fixed tibial tray cemented size 4 l (k123721) lot 156848: (b)(4) items manufactured and released on 08-feb-2016.Expiration date: 2021-01-23.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event.Gmk-revision 02.07.0412scf fixed tibial insert sc size 4/12mm (k103170) lot 165093: (b)(4) items manufactured and released on 12 october 2016.Expiration date: 2021-09-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold.Another similar event has been reported on this lot since 2017.
Event or Problem Description
The patient had a primary right knee surgery on (b)(6) 2018.On (b)(6) 2020, the patient came in reporting instability and the cause of the instability was unknown.The surgeon revised the femoral component, tibial tray, and insert.The surgery was completed successfully.Presently, on (b)(6) 2021, the patient came in due to signs of an infection and the pathogen is unknown.The surgeon removed all components and implanted an antibiotic spacer.The surgery was completed successfully.

• Brand Name: GMK-REVISION FEMUR PS SIZE 4 L
• Common Device Name: FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12188683
• Report Number: 3005180920-2021-00600
• Device Sequence Number: 1322754
• Product Code: JWH
• UDI-Device Identifier: 07630030821424
• UDI-Public: 07630030821424
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K102437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 07/19/2021

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: 07/20/2021
• Device Model Number: 02.07.2404L
• Device Catalogue Number: 02.07.2404L
• Device Lot Number: 164175
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 07/19/2021
• 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