GMK 3D Metal Tibial Tray 02.12.3D34RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630345710901), received between Aug 6, 2025 and Mar 30, 2026 — classified as 1 death, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (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.

• MalfunctionMar 30, 2026Malposition of Device

  IMPLANT MALALIGNMENT WAS IDENTIFIED SIX WEEKS AFTER THE PRIMARY SURGERY. APPROXIMATELY 8° OF VARUS ALIGNMENT OF THE TIBIAL COMPONENT AND 10° OF VALGUS ALIGNMENT OF THE FEMORAL COMPONENT WAS IDENTIFIED. THE PATIENT REPORTS A FLEXION CONTRACTURE. AT THIS TIME, NO REVISION PROCEDURE IS PLANNED. THE PRIMARY WAS PERFORMED USING MYKNEE GUIDES AND NEXTAR. NO INTRA-OPERATIVE OR IMMEDIATE POST-OPERATIVE ISSUES WERE REPORTED.

  Patient problems: Loss of Range of Motion

  MAUDE report 24710790 ↗
• DeathJan 19, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, PRIMARY KNEE SURGERY WAS PERFORMED AND COMPLETED WITHOUT COMPLICATIONS. BONE QUALITY WAS SUBOPTIMAL. ON (B)(6) 2026, THE PATIENT PRESENTED WITH PAIN DUE TO A BONE FRACTURE LEADING TO DISPLACEMENT OF THE TIBIAL TRAY. ALL COMPONENTS WERE REVISED USING A CEMENTED ZIMMER LCCK SYSTEM. THE PATIENT DID NOT REPORT ANY TRAUMATIC EVENT AS THE CAUSE. THE PATIENT PASSED AWAY AROUND (B)(6) 2026, DUE TO A BILATERAL CENTRAL PULMONARY EMBOLISM OCCURRING WHILE ON LOVENOX 60 MG OR DURING THE TRANSITION TO ELIQUIS 5 MG TWICE DAILY.

  Patient problems: Bone Fracture(s); Pulmonary Embolism

  MAUDE report 24108996 ↗
• InjuryAug 6, 2025Migration; Migration

  FOURTEEN (14) DAYS AFTER THE PRIMARY SURGERY, THE PATIENT REPORTED INSTABILITY AND DISCOMFORT, WITH AN UNKNOWN CAUSE. THE SURGEON FOUND THE TIBIA TO BE SOFT AND COLLAPSED DUE TO OSTEOPENIC BONE. A TIBIAL REVISION WAS PERFORMED, AND THE INSERT WAS UPSIZED FROM 11MM TO 14MM TO ADDRESS THE INSTABILITY. THE SURGERY WAS SUCCESSFUL.

  Patient problems: Joint Laxity

  MAUDE report 22727958 ↗