MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK REVISION - SC LINERS; INSERT SEMICONSTRAINED 14MM S4

Model Number	02.07.0414SCF
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Medical device site infection (4845)
Date of Event	06/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 01 october 2025: lot 2243642: (b)(4) items manufactured and released on 10-feb-2023.Expiration date: 2028-01-25.No anomalies found related to the problem.To date, 12 items of the same lot have been sold with no similar reported event during the period of review.Conclusions: 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
The patient had primary left knee surgery on (b)(6) 2025.On (b)(6) 2025, the patient came in due to signs of infection and the pathogen is unknown.The surgeon revised all medacta hardware and reimplanted permanent product.The surgery was completed successfully.Revision surgery for infection reason at 2 months from primary.The surgeon revised the insert to a same size insert.The surgery was completed successfully.
Additional Manufacturer Narrative
Correction: a second complaint was erroneously opened by the branch reporting the implantation of definitive devices on the (b)(6) 2025.The devices used for revision were listed in this complaint as revised devices instead of implanted.Following the above notification, mdr (b)(4) was sent reporting the explantation, due to infection, of the listed devices.As reported in the event description (b5) on the 10th of september just a spacer was removed.The devices listed in this report were all explanted-on the 30th of june and replaced by a spacer.This follow up is being sent to correct the event description and involved devices.Updated fields: b5 h11 additional revised devices: batch reviews performed on 17 november 2025: gmk-revision 02.07.0684l revision tibial tray size 4 left - finishing (k123721) lot 2312233: (b)(4) items manufactured and released on 03-oct-2023.Expiration date: 2028-oct-03.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 02.07.2404l femur revision ps cemented s.4l lot.2420356 (k102437) lot 2420356: (b)(4) items manufactured and released on 14-aug-2024.Expiration date: 2029-aug-01.No anomalies found related to the problem.To date, 19 items of the same lot have been sold with no similar reported event during the period of review.Gmk-revision 02.12.E002rp gmk-sphere resurfacing patella e-cross - s2 (k202022) lot 2429345: (b)(4) items manufactured and released on 03-dec-2024.Expiration date: 2029-nov-17.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.
Event or Problem Description
At about 3 months from primary, the patient came in due to signs of infection and the pathogen is unknown.The surgeon revised all medacta hardware and reimplanted permanent product.The surgery was completed successfully.(mdr (b)(4)) on (b)(6) 2025 all devices have been revised for infection and a spacer was implanted.On (b)(6) 2025 the spacer was removed and final devices implanted.

• Brand Name: GMK REVISION - SC LINERS
• Common Device Name: INSERT SEMICONSTRAINED 14MM S4
• 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: 23357727
• Report Number: 3005180920-2025-01012
• Device Sequence Number: 15671541
• Product Code: JWH
• UDI-Device Identifier: 07630030817878
• UDI-Public: 07630030817878
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K103170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

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: 02.07.0414SCF
• Device Lot Number: 2243642
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2023
• 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 Sex: Unknown