GMK Sphere Total Knee System 02.12.E0320FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630971261723), received between Sep 9, 2024 and May 5, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2026Device Appears to Trigger Rejection

  THE PATIENT HAD PRIMARY RIGHT KNEE SURGERY ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT CAME IN DUE TO PAIN AS THE RESULT OF A PERIPROSTHETIC FRACTURE OF THE PROXIMAL TIBIA AND THE CAUSE IS UNKNOWN. THE SURGEON REMOVED THE TIBIAL TRAY, INSERT, AND EXTENSION STEM AND IMPLANTED AN INSERT, TIBIAL TRAY, EXTENSION STEM, AND TIBIAL AUGMENTED SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2025, THE PATIENT CAME IN PRESENTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON ELECTED TO REVISE THE INSERT TO AN INSERT OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE 3R 20MM INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25077224 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD PRIMARY RIGHT KNEE SURGERY ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT CAME IN DUE TO PAIN AS A RESULT OF A PERIPROSTHETIC FRACTURE OF THE PROXIMAL TIBIA AND THE CAUSE IS UNKNOWN. THE SURGEON REMOVED THE TIBIAL TRAY, INSERT, AND EXTENSION STEM AND IMPLANTED A NEW INSERT, TIBIAL TRAY, EXTENSION STEM, AND TIBIAL AUGMENTED SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN PRESENTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT WITH AN INSERT OF THE SAME SIZE (AS 20 MM IS THE MAXIMUM AVAILABLE THICKNESS). THE SOFT TISSUE WAS SUTURED TO RESTORE STABILITY.THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 24558219 ↗
• InjuryJul 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD PAIN AFTER DISLOCATING THE KNEE WHEN BENDING DOWN TO TIE HIS SHOE. ABOUT 3 DAYS AFTER PRIMARY THE SURGEON REVISED ALL COMPONENTS TO HINGE COMPONENTS. DURING THE REVISION THE LINER WAS FOUND DETACHED FROM THE TIBIAL TRAY, THIS WAS DUE TO A CLOSE REDUCTION OF THE KNEE CAUSING THIS DISASSEMBLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. DURING THE PRIMARY A 20MM WAS IMPLANTED BECAUSE THE PATIENT HAD A VERY LAX KNEE.

  Patient problems: Joint Dislocation

  MAUDE report 22607934 ↗
• InjurySep 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD ANTERIOR KNEE PAIN AND THE CAUSE IS UNKNOWN. AT ABOUT 2 MONTHS POST PRIMARY THE SURGEON RESURFACED THE PATIENT'S NATURAL PATELLA AND REVISED THE POLY PER STANDARD PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 20167842 ↗