GMK Sphere Total Knee System 02.12.E0412FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07630971261839), received between May 14, 2024 and Apr 9, 2026 — classified as 7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION 8 MONTHS AFTER PRIMARY SURGERY. THE SURGEON PERFORMED A WASHOUT AND UPSIZED THE 12MM INSERT TO A 14MM INSERT AT HIS DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24826101 ↗
• InjuryMar 4, 2026Device Dislodged or Dislocated

  AT ABOUT 2 WEEKS FROM PRIMARY, THE PATIENT CAME IN DUE TO A DISSOCIATION OF THE INSERT FROM THE TIBIAL TRAY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE TRAY FROM A 12MM TO A 13MM TO PREVENT FUTURE DISLOCATION. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON BELIEVED IT WASN`T SEATED CORRECTLY DURING THE INITIAL SURGERY.

  Patient problems: Joint Dislocation

  MAUDE report 24504539 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 4 YEARS 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE POLY (12 TO 14MM) TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22573680 ↗
• InjuryNov 13, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 7 MONTHS AFTER 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 20674058 ↗
• InjuryJun 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 4 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING ANTERIOR KNEE PAIN AND MINOR INSTABILITY AND THE CAUSE WAS UNKNOWN. THE SURGEON REVISED THE INSERT (12MM) WITH A THICKER ONE (14MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19468102 ↗
• InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS AND 5 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (12MM) WITH A THICKER ONE (13MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19369810 ↗
• InjuryMay 14, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 1 MONTH 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 19309999 ↗