GMK Sphere Total Knee System 02.12.E0312FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07630971261600), received between Sep 1, 2023 and Jul 17, 2026 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO ANTERIOR KNEE PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATIENT'S NATURAL PATELLA AND REVISED THE INSERT FROM A 12MM INSERT TO A 13MM AT HIS DISCRETION.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 25854831 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME HAD INSTABILITY AND THE CAUSE IS UNKNOWN. THERE ARE NO INDICATIONS OF TRAUMA. AT ABOUT 1 YEAR AND 1 MONTH POST PRIMARY THE SURGEON REVISED THE FLEX 3R 12MM INSERT TO A FLEX 3R 17MM INSERT TO ADDRESS THE INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 25148959 ↗
• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO KNEE INSTABILITY AFTER ABOUT 9 MONTHS FROM PRIMARY. THERE WAS NO INDICATION OF TRAUMA OR BONE QUALITY ISSUES. THE SURGEON REVISED THE FLEX 3R - 12MM INSERT TO A FLEX 3R - 17MM INSERT FOR INCREASED STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 25123198 ↗
• InjuryJan 9, 2026Device Appears to Trigger Rejection

  REVISION SURGERY WAS PERFORMED 4 MONTHS AFTER THE PRIMARY SURGERY DUE TO KNEE INSTABILITY. THE SURGEON UPSIZED THE INSERT FROM 12 MM TO 17 MM TO PROVIDE IMPROVED STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 24020876 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. AT ABOUT 1 YEAR AND 6 MONTHS POST PRIMARY THE SURGEON UPSIZED THE POLY FROM 12MM TO 13MM FOR INCREASED STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23291309 ↗
• InjuryJul 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AFTER ONE MONTH FROM THE PRIMARY SURGERY, THE PATIENT PRESENTED WITH SIGNS OF INFECTION. THE SURGEON REVISED ALL THREE COMPONENTS AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: Medical device site infection

  MAUDE report 22506237 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 11 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (12MM) WITH A THICKER ONE (14MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 20731656 ↗
• InjurySep 19, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 5 MONTHS FROM 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 17773621 ↗
• InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. AT ABOUT 9 MONTHS AND A HALF AFTER PRIMARY THE SURGEON REVISED THE 12MM POLY WITH A 14MM POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17668766 ↗