GMK Sphere Total Knee System 02.12.T4I3LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030827150), received between Sep 13, 2018 and May 4, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (2 reports).

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.

• InjuryMay 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 MONTH AND HALF AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE SURGEON OBSERVED SIGNIFICANT ANTERIOR SLOPE AND MINOR MALROTATION OF THE TIBIAL IMPLANT AND THE CAUSE IS UNKNOWN. THE SURGEON DECIDED TO REMOVE ALL COMPONENTS AND REVISE THEM WITH COMPETITOR COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 16866422 ↗
• InjuryJun 25, 2021Loose or Intermittent Connection

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIAL BASEPLATE AND THE CAUSE OF THE LOOSE TIBIAL BASEPLATE IS UNKNOWN. 7 MONTHS AFTER PRIMARY SURGERY THE SURGEON REVISED THE TIBIAL TRAY, INSERT, AND ADDED A FLUTED EXTENSION STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 12068016 ↗
• InjurySep 13, 2018Loose or Intermittent Connection

  REVISION SURGERY PERFORMED DUE TO LIGAMENTS LAXITY 2 YEARS AND 3 MONTHS AFTER PRIMARY SURGERY. GMK-SPHERE WAS REPLACED BY A GMK-HINGE.

  Patient problems: Failure of Implant

  MAUDE report 7872477 ↗