GMK 3D Metal Tibial Tray 02.12.3D04RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630345710840), received between May 12, 2025 and Dec 24, 2025 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 24, 2025Failure to Osseointegrate; Failure to Osseointegrate

  10 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT PRESENTED WITH PAIN DUE TO LOOSENING OF THE FEMORAL COMPONENT AND TIBIAL TRAY OF UNKNOWN CAUSE. THE SURGEON REVISED THE GMK SPHERIKA FEMORAL COMPONENT TO A GMK REVISION P.S. AND REVISED THE GMK 3D METAL SIZE 4R TIBIAL TRAY TO A GMK REVISION TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23886584 ↗
• InjuryMay 12, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A METAL ALLERGY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22000383 ↗