MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA GMK PRIMARY TOTAL KNEE SYSTEM; TIBIAL INSERT PS FIX S.3 / 12 MM

Model Number	02.07.0312PSF
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	02/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch reviews performed on 09 february 2026: gmk-primary 02.07.312psf tibial insert ps fix s.3 / 12 mm (k090988) lot 145633: (b)(4) items manufactured and released on 24-nov-2014.Expiration date: 2019-oct-30.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 02.07.2203l femoral component cemented ps size 3 / left (k090988) lot 168673: (b)(4) items manufactured and released on 12-apr-2017.Expiration date: 2022-feb-30.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.F11030 primary extension stem d 11mm l30mm (k133630) lot 168578: (b)(4) items manufactured and released on 28-mar-2017.Expiration date: 2022-mar-2022.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.
Event or Problem Description
The patient had a knee revision due to infection.During the surgeon the femur was found septic loosen.All devices revised successfully at about 7 years and 3 months post primary.

• Brand Name: GMK PRIMARY TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL INSERT PS FIX S.3 / 12 MM
• 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: 24455600
• Report Number: 3005180920-2026-00127
• Device Sequence Number: 10007133
• Product Code: JWH
• UDI-Device Identifier: 07630030817168
• UDI-Public: 07630030817168
• Combination Product (Y/N): N
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 02/26/2026

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: 10/31/2019
• Device Model Number: 02.07.0312PSF
• Device Lot Number: 145633
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2014
• 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: 55 YR
• Patient Sex: Female