MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; FEMORAL COMPONENT CEMENTED STD SIZE6 / LEFT

Model Number	02.07.2006L
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	03/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 15 years from the primary, the patient came in due to a total knee infection and the pathogen is unknown.The surgeon revised all medacta products from the primary surgery to competitor products.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 11 march 2026: gmk-primary 02.07.2006l femoral component cemented std size 6 / left (k090988) lot 103706: (b)(4) items manufactured and released on 23-dec-2010.Expiration date: 30-nov-2015.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-primary 02.07.1206l tibial tray fix cemented s.6l (k090988) lot 103875: (b)(4) items manufactured and released on 16-dec-2010.Expiration date: 30-nov-2015.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-primary 02.07.0610fuc tibial insert u.C.Fix s.6 / 10 mm (k090988) lot 092743: (b)(4) items manufactured and released on 16-dec-2009.Expiration date: 31-oct-2014.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-primary 02.07.0035rp patella resurfacing s.3 (new generation) (k090988) lot 103886: (b)(4) items manufactured and released on 10-jan-2011.Expiration date: 30-nov-2015.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.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.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: FEMORAL COMPONENT CEMENTED STD SIZE6 / LEFT
• 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: 24700708
• Report Number: 3005180920-2026-00267
• Device Sequence Number: 10046713
• Product Code: JWH
• UDI-Device Identifier: 07630030820250
• UDI-Public: 07630030820250
• Combination Product (Y/N): N
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 03/26/2026

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 Expiration Date: 11/30/2015
• Device Model Number: 02.07.2006L
• Device Lot Number: 103706
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2010
• 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