GMK 3D Metal Tibial Tray 02.12.3D05LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630345710857), received between Jun 27, 2025 and Aug 12, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2026Loosening of Implant Not Related to Bone-Ingrowth

  Revision surgery due to 3D metal cemented tibial tray loosening after about 8 months from primary. The surgeon revised the GMK 3DMetal Tibial Tray Size 5L to a GMK Tibial Tray Cemented Left S4 and revised the GMK-SPHERE tibial insert E-Cross - Flex 5L - 10mm to a GMK-SPHERE tibial insert E-Cross - Flex 4L - 14mm.

  Patient problems: Aseptic loosening

  MAUDE report 50222761 ↗
• InjuryAug 11, 2026Device Appears to Trigger Rejection

  The patient had primary left knee surgery on (b)(6) 2026. On (b)(6) 2026, the patient had signs of infection and the pathogen is unknown. The surgeon performed a washout and revised the Flex 5L - 11mm insert to a same size insert. The surgery was completed successfully. On (b)(6) 2026, the patient continued to have signs of infection and the pathogen is unknown. The surgeon performed a washout and revised the GMK 3DMetal Tibial Tray Size 5L to a Fixed Tibial Tray Size 5 L - TiNbN Coating, revised the Flex 5L - 11mm to a same size insert, and revised the Porous TiGrowthC+HA 5+L femoral component to a S5+L Cemented TiNbN femoral component. The surgery was completed successfully.

  Patient problems: Medical device site infection

  MAUDE report 50209599 ↗
• InjuryJun 27, 2025Osseointegration Problem; Osseointegration Problem

  THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO TIBIAL LOOSENING (CEMENTLESS) AND THE CAUSE IS UNKNOWN. IT WAS NOTED THAT THE CT SCAN SHOWED NO INGROWTH ON THE KEEL. ABOUT 7 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL COMPONENTS (GMK-SPHERIKA REIMPLANTED), AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 22345488 ↗