GMK Sphere Total Knee System 02.12.0021LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030862519), received between Nov 16, 2018 and May 25, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryMay 25, 2021Insufficient Device Problem Information

  THE PATIENT CAME IN REPORTING KNEE PAIN AND STIFFNESS. THE CAUSE OF THE KNEE PAIN AND STIFFNESS IS UNKNOWN. 5 MONTHS AFTER PRIMARY THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT AND ADDED AN EXTENSION STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 11877173 ↗
• InjuryNov 16, 2018Loose or Intermittent Connection

  REVISION SURGERY PERFORMED AFTER 2 YEARS FROM THE PRIMARY DUE TO TIBIAL PLATEAU LOOSENING, ALL HARDWARE WERE REMOVED, THE FEMUR WAS WELL FIXED. THE CEMENT WAS NOT ADHERENT TO THE INTERNAL SURFACES OF BOTH COMPONENTS REMOVED.

  Patient problems: Joint Disorder

  MAUDE report 8077523 ↗