MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK-REVISION 02.07.2405R FEMUR REVISION PS SIZE 5 R LOT. 2003109; KNEE FEMUR REVISION

Catalog Number	02.07.2405R
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2018.On (b)(6) 2021, the patient came in reporting instability due to laxity and the cause of the laxity was unknown.The surgeon revised the gmk-sphere tibial insert - flex s5r - 14 mm with a gmk-sphere tibial insert - flex s5r - 17 mm and the surgery was completed successfully.On (b)(6) 2021, the patient came in due to signs of an infection and the pathogen was unknown.The surgeon performed a washout and revised the poly and the surgery was completed successfully.On (b)(6) 2022, 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.On (b)(6) 2022, the surgeon removed the femur and insert that was implanted to act as a spacer and implanted a new femur and insert with antibiotic cement.The surgery was completed successfully.On (b)(6) 2023, the surgeon removed the femur and insert that was implanted to act as a spacer and implanted revision knee components.The surgery was completed successfully.Presently, on (b)(6) 2023, the patient came in due to signs of infection and the pathogen is unknown.The surgeon performed a washout and implanted a femoral component and full-pe tibial component to act as a spacer, along with antibiotics, due to infection.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2023: lot 2003109: (b)(4) items manufactured and released on 01-jul-2020.Expiration date: 2025-06-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Other devices involved: batch review performed on (b)(6) 2023.Gmk-revision 02.07.0410scf fixed tibial insert sc size 4/10mm (k103170) lot 2000822: (b)(4) items manufactured and released on 01-apr-2020.Expiration date: 2025-02-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Gmk-revision 02.07.0684r revision fixed tibial tray cemented size 4 r (k123721) lot 2003091: (b)(4) items manufactured and released on 10-jul-2020.Expiration date: 2025-07-01.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Gmk-revision 02.07.Fcl15065 extension stem - fluted ø 15 l 65 (k120790) lot 2208518: (b)(4) items manufactured and released on 20-jul-2022.Expiration date: 2027-07-12.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Gmk-revision 02.07.Fcl18105 extension stem - fluted ø 18 l 105 (k120790) lot 2109488: (b)(4) items manufactured and released on 09-nov-2021.Expiration date: 2026-10-27.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: GMK-REVISION 02.07.2405R FEMUR REVISION PS SIZE 5 R LOT. 2003109
• Common Device Name: KNEE FEMUR REVISION
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17697145
• Report Number: 3005180920-2023-00674
• Device Sequence Number: 6746161
• Product Code: JWH
• UDI-Device Identifier: 07630030821455
• UDI-Public: 07630030821455
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K102437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 09/07/2023

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 Catalogue Number: 02.07.2405R
• Device Lot Number: 2003109
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 66 KG