GMK Sphere Total Knee System 02.12.E0212FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630971261365), received between Jun 1, 2022 and Feb 24, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2026Device Dislodged or Dislocated

  AT ABOUT 5 MONTHS FROM THE PRIMARY, THE PATIENT PRESENTED WITH PAIN DUE TO A DISLOCATION BETWEEN THE CEMENTED FEMORAL COMPONENT AND TIBIAL INSERT AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMUR FROM GMK-SPHERIKA TO A GMK-REVISION AND THE INSERT (FROM 12MM TO 17MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 24429833 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 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 (14MM) TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22025625 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 6 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING ANTERIOR KNEE PAIN AND LAXITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (12 TO 17 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity; Pain

  MAUDE report 20683571 ↗
• InjuryApr 24, 2024Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO THE PATELLA DISLOCATING LATERALLY AND THE CAUSE IS UNKNOWN. THE SURGEON RELEASED THE PATELLA MORE LATERALLY AND UPSIZED THE INSERT (FROM 12 MM TO 17 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19174408 ↗
• InjuryMar 31, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023 THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION, THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16655503 ↗
• InjuryJun 1, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 3 MONTHS AND A HALF AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 14560051 ↗