MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION FEMUR REVISION PS #4 R; KNEE FEMORAL COMPONENT

Model Number	02.07.2404R
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch reviews performed on 04.Aug.2021: lot 1810569: (b)(4) items manufactured and released on 21-mar-2019.Expiration date: 2024-march-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without a similar reported event.Other components involved: gmk-revision 02.07.0683r revision fixed tibial tray cemented size 3 r lot.186398 k123721 lot 186398: (b)(4) items manufactured and released on 29-oct-2018.Expiration date: 2023-oct-18.No anomalies found related to the problem.To date, all items of the same lot have been sold without a similar reported event.Gmk-revision 02.07.0312scf fixed tibial insert sc size 3/12mm lot.189532 k103170.Lot 189532: (b)(4) items manufactured and released on 4-march-2019.Expiration date: 2024-feb-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without a similar reported event.Gmk-revision 02.07.0003 offset connector 3 mm lot.1900664 k102437.Lot 1900664: (b)(4) items manufactured and released on 02-apr-2019.Expiration date: 2024-march-23.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without a similar reported event.Gmk-revision 02.07.Fcl22065 extension stem - fluted ø 22 l 65 lot.189595 k120790.Lot 189595: (b)(4) items manufactured and released on 22-feb-2019.Expiration date: 2024-feb-11.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without a similar reported event.Gmk-revision 02.07.Fcl18065 extension stem - fluted ø 18 l 65 lot.1810602 k120790.Lot 1810602: (b)(4) items manufactured and released on 27-feb-2019.Expiration date: 2024-feb-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without a similar reported event.Gmk-revision 02.07.0034rp patella resurfacing size 2 lot.1810561 k090988.Lot 1810561: (b)(4) items manufactured and released on 1-march-2019.Expiration date: 2024-feb-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without a similar reported event.Gmk-revision 02.09.Ta305 tibial augmentation size 3/5mm lot.189435 k130299.Lot 189435: 56 items manufactured and released on 28-march-2019.Expiration date: 2024-march-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event (2 pieces of the same lot reported in this complaint).
Event or Problem Description
2 years and 1 month after the primary surgery the patient came in due to signs of an infection and the pathogen is unknown.The surgeon performed a washout, removed all components and implanted an antibiotic spacer.The surgery was completed successfully.Previously this patient was implanted with competitor implants.

• Brand Name: GMK-REVISION FEMUR REVISION PS #4 R
• Common Device Name: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 12353526
• Report Number: 3005180920-2021-00678
• Device Sequence Number: 3974013
• Product Code: JWH
• UDI-Device Identifier: 07630030821431
• UDI-Public: 07630030821431
• 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: 2019
• 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): 08/23/2021

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: 03/11/2024
• Device Model Number: 02.07.2404R
• Device Catalogue Number: 02.07.2404R
• Device Lot Number: 1810569
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 08/23/2021
• 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