GMK Sphere Total Knee System 02.12.E0413FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07630971261877), received between Feb 2, 2022 and Jul 15, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2026Device Appears to Trigger Rejection

  AT 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE GMK-SPHERE TIBIAL INSERT E-CROSS - FLEX 4L - 13MM TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25822783 ↗
• InjuryMay 12, 2026Device Dislodged or Dislocated

  AT 3 YEARS 1 MONTH FROM PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A DISENGAGEMENT OF THE LINER FROM THE TIBIAL TRAY. THERE WAS NO TRAUMA INDICATED AND THE SURGEON DID NOT HAVE ANY ISSUES SNAPPING THE POLY IN DURING THE PRIMARY SURGERY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT WITH ONE OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 25148977 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO KNEE STIFFNESS PATIENT CAME IN PRESENTING STIFFNESS ABOUT 1 YEAR AND 4 MONTHS AFTER PRIMARY SURGERY. THE SURGEON REVISED 13MM INSERT TO A 20MM INSERT, REVISED THE FEMORAL COMPONENT TO A TINBN COATED FEMORAL COMPONENT, AND REVISED THE TIBIAL TRAY TO A TINBN COATED TIBIAL TRAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 24871666 ↗
• InjuryNov 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ON (B)(6) 2025, THE PATIENT HAD PRIMARY LEFT KNEE SURGERY. ON (B)(6) 2025, THE PATIENT CAME IN PRESENTING AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON REVISED THE TRAY, INSERT, AND FEMUR. THE SURGERY WAS SUCCESSFULLY COMPLETED (B)(4). PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN PRESENTING AN INFECTION AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23510670 ↗
• InjuryNov 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 WEEKS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23477200 ↗
• InjurySep 12, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 10 MONTHS THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 23036822 ↗
• InjuryFeb 23, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2023. ON 23 OCTOBER 2023, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18765735 ↗
• InjuryDec 20, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18364385 ↗
• InjuryFeb 2, 2022Unstable

  AT 20 DAYS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE INSERT (13 MM TO 14 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 13423111 ↗