GMK Total Knee System 02.12.28T3I4RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630040711630), received between Feb 16, 2022 and Feb 16, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.

• InjuryFeb 16, 2022Loose or Intermittent Connection; Improper or Incorrect Procedure or Method; Appropriate Device Problem Term/Code Not Available

  COMPLETE REVISION OF TKA IMPLANTS BECAUSE OF INCORRECT IMPLANTATION. THE MAIN PROBLEM WAS, THE PATIENT'S LEG WAS INITIAL IN THE VARUS AND AFTER THE PRIMARY SURGERY, IT WAS IN THE VALGUS. ANOTHER PROBLEM WAS SOME LOOSE CEMENT THAT HAD BEEN LEFT IN THE SURROUNDING AREA. AT 8 MONTHS FROM PRIMARY THE SURGEON CHANGED THE ANGLE OF THE KNEE AND IMPLANTED A NEW GMK-SPHERE.

  Patient problems: Insufficient Information

  MAUDE report 13541410 ↗