GMK Sphere Total Knee System 02.12.0511CRLRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630040707633), received between Jan 21, 2021 and Jul 21, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING STIFFNESS AND THE CAUSE IS UNKNOWN. THE SURGEON DOWNSIZED THE LINER (11MM TO 10MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 17371179 ↗
• InjuryJan 21, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY DUE TO DISENGAGEMENT OF THE INSERT FROM THE TIBIAL TRAY 3 MONTHS AFTER THE PRIMARY. THE SURGEON REVISED THE INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 11206648 ↗