MAUDE Adverse Event Report: Medacta International SA GMK Primary Total Knee System; GMK Tibial Tray Cemented Right S4

Model Number	02.07.1204R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	07/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 3 years 10 months after the primary, the patient came in reporting instability and the cause of the instability is unknown.The surgeon revised all components to gmk-hinge components and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 24 july 2026 gmk-sphere 02.07.1204r gmk tibial tray cemented right s4 (k090988) lot.2119383: (b)(4) items manufactured and released on 25-may-2022.Expiration date: 2027-05-08.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported events during the period of review.Gmk-sphere 02.12.0024r femoral component sphere cemented size 4+ r (k090988) lot.2202830: (b)(4) items manufactured and released on 10-may-2022.Expiration date: 2027-04-27.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported events during the period of review.Gmk-sphere 02.12.0410crr gmk sphere cr tibial insert s4r 10mm (k181635) lot.2119301: (b)(4) items manufactured and released on 07-march-2022.Expiration date: 2027-02-16.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event during the period of review.Root cause:developmental instability is a rather commonly described possible complication following tka, because soft tissue may stretch and provide insufficient stability.The investigation does not indicate any potential manufacturing related issue or systemic deficiency.

• Brand Name: GMK Primary Total Knee System
• Common Device Name: GMK Tibial Tray Cemented Right S4
• 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: 50114132
• Report Number: 3005180920-2026-00804
• Device Sequence Number: 20159887
• Product Code: JWH
• UDI-Device Identifier: 07630030819919
• UDI-Public: 07630030819919
• Combination Product (Y/N): N
• PMA/510(K) Number: K090988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/03/2026

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: 02.07.1204R
• Device Lot Number: 2119383
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2022
• 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: 76 YR
• Patient Sex: Male
• Patient Race: White