MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK REVISION TOTAL KNEE SYSTEM; FEMUR REVISION PS CEMENTED S.4R

Model Number	02.07.2404R
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	11/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 november 2024.Lot 2212787: (b)(4) items manufactured and released on 21-sep-2022.Expiration date: 2027-09-04.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Additional items involved in the event; batch review performed on 25 november 2024.Gmk-revision 02.07.0310scf fixed tibial insert semiconstrained s.3 / 10 mm (k103170) lot.2311008 lot 2311008: (b)(4) items manufactured and released on 15-jun-2023.Expiration date: 2028-05-24.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 02.07.0683r revision tibial tray size 3 right (k123721) lot.2347604 lot 2347604: (b)(4) items manufactured and released on 09-apr-2024.Expiration date: 2029-09-12.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.Infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.
Event or Problem Description
Revision due to infection and the pathogen is unknown.At about 1 month after a precedent revision for infection the surgeon performed a washout and revised the femur, the tibial insert and the tibia.The surgery was completed successfully.The patient comes from a precedent revision surgery for infection (case code (b)(4), emdr (b)(4)).
Additional Manufacturer Narrative
Updated fields: b5, to include the explantation of the spacer and implantation of permanent products.
Event or Problem Description
The patient had a primary knee surgery on (b)(6) 2023.On (b)(6) 2024, the patient came in reporting pain due to an infection and the pathogen was unknown.The surgeon revised all revised all medacta hardware and reimplanted permanent product.The surgery was completed successfully.(mdr (b)(4)).Subsequently, on (b)(6) 2024, the patient came in due to signs of infection.The surgeon performed a washout and revised the gmk revision femur, ps tibial insert, and gmk revision tiba and inserted a spaces along with primary femur and insert to hold the joint temporarly.(current mdr (b)(4)).On the (b)(6) 2025 the surgeon explanded the spacer and temporary components and implanted gmk hinge components.The surgery was completed successfully.

• Brand Name: GMK REVISION TOTAL KNEE SYSTEM
• Common Device Name: FEMUR REVISION PS CEMENTED S.4R
• 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: 20852293
• Report Number: 3005180920-2024-01045
• Device Sequence Number: 8100729
• Product Code: JWH
• UDI-Device Identifier: 07630030821431
• UDI-Public: 07630030821431
• 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: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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 Model Number: 02.07.2404R
• Device Lot Number: 2212787
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2022
• 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: 68 YR
• Patient Sex: Female