MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; FIXED TIBIAL TRAY CEMENTED RIGHT, SIZE 4

Model Number	02.07.1204R
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	07/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2025, the branch informed us that on (b)(6) 2025 the patient came in to have the antibiotic spacers revised, however, due to a size 7 revision femur not being available, the surgeon is revision to competitor products.
Event or Problem Description
The patient had signs of an infection and the pathogen is unknown.At about 9 months post primary the surgeon performed a washout, removed all implants, and implanted an antibiotic spacer.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 28 july 2025: gmk-spherika 02.07.1204r tibial tray fix cemented s.4r (k090988) lot 2403366: (b)(4) items manufactured and released on 01- jul-2024.Expiration date: 2029-06-13.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.Additional implant revised, batch review performed on 28 july 2025: gmk-spherika 02.12.E0411fr gmk-sphere tibial insert e-cross - flex 4r - 11mm (k202022) lot 2400958: (b)(4) items manufactured and released on 26-jul-2024.Expiration date: 2029-jul-07.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-spherika 02.12.Ka07r gmk spherika femoral component s7r cemented (k211004) lot 2406699: (b)(4) items manufactured and released on 29-feb-2024.Expiration date: 2029-feb-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.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.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: FIXED TIBIAL TRAY CEMENTED RIGHT, SIZE 4
• 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: 22664212
• Report Number: 3005180920-2025-00742
• Device Sequence Number: 17099922
• Product Code: JWH
• UDI-Device Identifier: 07630030819919
• UDI-Public: 07630030819919
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 10/22/2025

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: 02.07.1204R
• Device Lot Number: 2406699
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2024
• 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: 70 YR
• Patient Sex: Male