GMK Sphere Total Knee System 02.12.E0513FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630971262119), received between Jun 12, 2024 and Apr 30, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  AT2 YEARS 1 MONTH, THE PATIENT CAME IN PRESENTING ANTERIOR KNEE PAIN AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA. THE SURGEON RESURFACED THE PATIENT`S NATURAL PATELLA AND REVISED THE 13MM INSERT TO A 14MM INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 25039780 ↗
• InjurySep 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION FOR INFECTION AT ABOUT 1 YEAR AND 2 MONTHS POST PRIMARY AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Medical device site infection

  MAUDE report 23070933 ↗
• InjuryJul 3, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 1 WEEK FROM PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22395932 ↗
• InjuryMay 7, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A KNEE INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 2 MONTHS POST PRIMARY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 21974539 ↗
• InjuryJun 12, 2024Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO A PATELLA THAT WAS DISLOCATING LATERALLY. THE KNEE WAS LAX. AT ABOUT 2 MONTHS POST PRIMARY THE SURGEON IMPLANTED A 17MM POLY AND SUTURED THE SOFT TISSUE AND THE PATIENT'S PATELLA WAS STABLE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 19517428 ↗