MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FEMUR REVISION PS SIZE 3 R; CEMENTED FEMORAL COMPONENT

Model Number	02.07.2403R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 october 2020, lot 185069: (b)(4) items manufactured and released on 26-sep-2018.Expiration date: 2023-09-13.No anomalies found related to the problem.To date, 24 items of the same lot have been already sold without any similar reported event.Additional implant involved: gmk-revision 02.07.1202r fixed tibial tray cemented size 2 r (k090988) lot.1906229, batch review performed on 30 october 2020, lot 1906229: (b)(4) items manufactured and released on 08-jan-2020.Expiration date: 2024-12-14.No anomalies found related to the problem.To date, 18 items of the same lot have been already sold without any similar reported event.Additional implant involved: gmk-revision 02.07.0214scf fixed tibial insert sc size 2/14mm (k103170) lot.177654, batch review performed on 30 october 2020, lot 177654: (b)(4) items manufactured and released on 23-jan-2018.Expiration date: 2023-01-10.No anomalies found related to the problem.To date, 7 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in, 6 months after previous surgery, due to signs of an infection and the pathogen is unknown.The surgeon removed all implants and implanted another temporary spacer to treat the infection.The surgery was completed successfully.Previously this patient had several revision surgeries (6th for the right knee and 3rd for the left knee).The reason for the previous revision is unknown beside the 4th revision of the right knee when the patient had a fall and ruptured extensor mechanism and the last, performed due to infection.

• Brand Name: GMK-REVISION FEMUR REVISION PS SIZE 3 R
• Common Device Name: CEMENTED FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 10867999
• Report Number: 3005180920-2020-00810
• Device Sequence Number: 2521750
• Product Code: JWH
• UDI-Device Identifier: 07630030821417
• UDI-Public: 07630030821417
• Combination Product (Y/N): N
• 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: 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): 11/19/2020

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: 09/13/2023
• Device Model Number: 02.07.2403R
• Device Catalogue Number: 02.07.2403R
• Device Lot Number: 185069
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 11/19/2020
• 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