GMK Sphere Total Knee System 02.12.E0214FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630971261433), received between Nov 20, 2024 and Apr 15, 2026 — classified as 5 injuries.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, ABOUT 1 MONTH AFTER THE PREVIOUS REVISION SURGERY, THE PATIENT CAME IN PRESENTING INSTABILITY WITH THE KNEE FEELING LOOSE AND THE CAUSE IS UNKNOWN. THERE WAS NO TRAUMA REPORTED. THE SURGEON REVISED THE 14MM INSERT TO A 20MM INSERT TO ADDRESS THE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD PRIMARY LEFT KNEE SURGERY ON (B)(6) 2025 WITH GMK-SPHERIKA IMPLANTS AND A MOTO PATELLA. ON (B)(6) 2025, THE PATIENT CAME IN DUE TO DISLOCATION OF THE PATELLA AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A MANUAL LATERAL RELEASE AND TIGHTENED THE PATELLA WITH SUTURES. THE SURGERY ALSO REVISED THE POLY DURING THE PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY (B)(4). ON (B)(6) 2026, THE PATIENT CAME IN PRESENTING INSTABILITY DUE TO THE 10MM TIBIAL INSERT NOT BEING FULLY ENGAGED. THE SURGEON REVISED THE 10MM INSERT AND IMPLANTED A 14MM INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY (B)(4).

  Patient problems: Joint Laxity

  MAUDE report 24882479 ↗
• InjuryNov 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT1 YEAR AND 5 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY. THE SURGEON UPSIZED THE LINER (14 TO 20MM) TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23669506 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 1 YEAR 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE INSERT FROM 14MM TO 20MM TO INCREASE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23310300 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 4 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON UPSIZED THE INSERT (FROM 14 TO 17 MM) TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22936843 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE INSERT AND FEMORAL COMPONENT AND IMPLANTED MORE CONSTRAINED COMPONENTS.

  Patient problems: Joint Laxity

  MAUDE report 20731949 ↗