GMK Sphere Total Knee System 02.12.E0211FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630971261310), received between Sep 17, 2025 and Jan 29, 2026 — classified as 2 injuries.

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.

• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD KNEE LAXITY AND THE CAUSE IS UNKNOWN. AT ABOUT 1 YEAR AND 8 MONTHS POST PRIMARY THE SURGEON UPSIZED THE INSERT FROM 11MM TO 14MM TO ADDRESS THE PATIENT`S INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24208606 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 2 YEARS 6 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY. THE SURGEON REVISED THE INSERT AND UPSIZED IT FOR INCREASED STABILITY (FROM 11 TO 13 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23070845 ↗