GMK Revision Total Knee System 02.07.FCL18105Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030823060), received between Feb 10, 2021 and Apr 20, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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.

• InjuryApr 20, 2026Migration

  X-RAYS TAKEN 8 YEARS 7 MONTHS AFTER THE PRIMARY REVEALED THAT THE EXTENSION STEM SCREW CONNECTING THE FEMUR AND THE OFFSET WAS UNSCREWED AND HAD MIGRATED.THE SCREW WAS REMOVED THROUGH A SMALL INCISION.THE TORQUE LIMITER WAS USED DURING PRIMARY SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24924648 ↗
• InjuryApr 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO VIA FALSA OF THE EXTENSION STEM FEMORAL COMPONENT AT 2 WEEKS FROM THE PRIMARY. FEMORAL BONE PERFORATION IS VISIBLE FROM THE X-RAYS. POOR BONE QUALITY. ALL FEMORAL COMPONENTS AND INLAY WERE SUCCESSFULLY REVISED.

  Patient problems: Bone Fracture(s)

  MAUDE report 19048600 ↗
• InjuryFeb 10, 2021Loose or Intermittent Connection

  THROUGH THE X-RAYS THE SURGEON RECOGNIZED A SCREW UNSCREWED 1 YEAR AND 1 MONTH AFTER THE LAST SURGERY. PROBABLY THE SCREW COMES FROM THE FEMORAL EXTENTION STEM, THE ENTIRE CONSTRUCT IS COMPOSED OF AUGMENTS, STEMS AND OFFSETS. NO REVISION SURGERY IS PLANNED AT THE MOMENT. FOR ALL SCREWS, IT WAS CONFIRMED THAT THE CORRECT TORQUE LIMITER, WHERE NECESSARY, WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 11307400 ↗