GMK 3D Metal Tibial Tray 02.12.3D03LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630345710819), received between May 25, 2026 and May 25, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Implant subsidence” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 25, 2026Implant subsidence

  AT ABOUT 5 WEEKS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A TIBIAL TRAY THAT COLLAPSED INTO THE VALGUS. BONE WAS VERY SOFT WITH SIGNIFICANT RESORPTION ON THE LATERAL TIBIAL PLATEAU.DURING PRIMARY SURGERY, THE SURGEON ASSESSED THE BONE QUALITY AND INITIALLY FELT THAT A PRIMARY PRESS-FIT KNEE IMPLANT WOULD BE APPROPRIATE DESPITE THE PATIENT`S HIGH BMI AND AGE.THE SURGEON REVISED THE GMK 3DMETAL TIBIAL TRAY SIZE 3L TO A REV. TIBIAL TRAY S3 ALONG WITH TIBIAL CONES AND AUGMENTS, AND REVISED THE 11MM INSERT TO A 12MM ONE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 25268620 ↗