GMK 3D Metal Tibial Tray 02.12.3D02RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630345710802), received between Jul 11, 2025 and Jan 23, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration” (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.

• InjuryJan 23, 2026Osseointegration Problem

  AT ABOUT 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO INSTABILITY AS THE RESULT OF TIBIAL LOOSENING AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE TIBIAL TRAY FROM GMK 3D METAL 2R CEMENTLESS TO A GMK CEMENTED S2 AND UPSIZED THE INSERT FROM 12MM TO 17MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 24162767 ↗
• InjuryAug 13, 2025Migration; Migration

  AT 2 WEEKS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO PAIN THAT WAS IDENTIFIED BY THE SURGEON TO BE CAUSED BY A COLLAPSED TIBIA. PATIENT'S BONE QUALITY WAS POOR AND TIBIAL TRAY UNDERSIZED IMPLANTED IN PRIMARY. THE SURGEON UPSIZED THE INSERT AND TIBIAL BASEPLATE TO PREVENT REPEAT COMPLICATIONS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 22792529 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING PAIN AND STIFFNESS IN THE KNEE DUE TO A NICKEL SENSITIVITY. ABOUT 7 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL COMPONENTS TO SENSITIN COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT BROUGHT UP NICKEL SENSITIVITY TO THE DOCTOR BEFORE PRIMARY BUT THE SURGEON WAS NOT CONCERNED. TURNED OUT PATIENT DID HAVE NICKEL SENSITIVITY AND HAD TO HAVE ALL COMPONENTS REVISED.

  Patient problems: Hypersensitivity/Allergic reaction; Loss of Range of Motion

  MAUDE report 22477460 ↗