MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; TIBIAL TRAY FIX CEMENTED S.2R

Model Number	02.07.1202R
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 16 july 2026 gmk-primary 02.07.1202r tibial tray fix cemented s.2r (k090988) lot.2518198: (b)(4) items manufactured and released on 10-dec-2025.Expiration date: 2030-11-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Gmk-primary 02.07.2202r femur ps cemented size 2 r (k090988) lot.2318096: (b)(4) items manufactured and released on 10-oct-2023.Expiration date: 2028-09-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Gmk-primary 02.07.0210psf tibial insert ps fixed size 2/10mm (k090988) lot.2528257: (b)(4) items manufactured and released on 22-jan-2026.Expiration date: 2030-12-10.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Clinical evaluation: an early postoperative periprosthetic joint infection occurred approximately five and a half weeks after primary right cemented total knee arthroplasty and required removal of all components with placement of an antibiotic spacer.A specific potential contamination event occurred during the primary procedure when a medacta representative lost consciousness and fell onto the surgical drapes close to the open surgical field.This event provides a medically plausible route of contamination and may have contributed to the subsequent infection.However, the available evidence does not confirm a direct causal relationship, because the sterile-field breach is not fully characterized and microbiological, surgical, and patient-risk information is unavailable.No evidence currently supports an intrinsic malfunction, manufacturing defect, or mechanical failure of the implanted gmk primary components.The root cause of the infection cannot be definitively determined with the information at hand.Root cause: 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 surgery was performed 1 month and half after the primary due to infection.The surgeon removed all implants and placed antibiotic spacer.During the primary surgical procedure the medacta representative experienced a medical event, lost consciousness, and fell into the open surgical field on the surgical draps before collapsing onto the floor.Following the event, the surgeon initiated the disinfection protocol due to the potential contamination risk of the surgical site.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL TRAY FIX CEMENTED S.2R
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 25904707
• Report Number: 3005180920-2026-00733
• Device Sequence Number: 15549906
• Product Code: JWH
• UDI-Device Identifier: 07630030819872
• UDI-Public: 07630030819872
• Combination Product (Y/N): N
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2026

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: 02.07.1202R
• Device Lot Number: 2518198
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 07/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2025
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 65 KG