GMK Sphere Total Knee System 02.12.E0413FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07630971261884), received between Aug 19, 2022 and Jul 14, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY AFTER 2 MONTHS FROM THE PRIMARY DUE TO INFECTION. THE SURGEON REVISED THE INSERT WITH A SAME-SIZE ONE.

  Patient problems: Medical device site infection

  MAUDE report 25813730 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO KNEE INSTABILITYAFTER 1 YEAR AND 3 MONTHS FROM THE PREVIOUS SURGERY, WHICH WAS DUE TOPCL RUPTURE/INSTABILITY. THE SURGEON REVISED THE INSERT FROM 13 MM TO 17 MM TO ADDRESS THE INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 25242299 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 4 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (FROM13MMTO 17MM) TO ADDRESS THE INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24871653 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SECONDARY PATELLA BONE RESURFACING DUE TO PERSISTENT PATELLOFEMORAL PAIN APPROXIMATELY 2 YEARS AND 3 MONTHS AFTER INITIAL SURGERY. INLAY REPLACEMENT FROM 13MM TO 17MM TO FURTHER IMPROVE KNEE STABILITY ACCORDING TO SURGEONS NEWER PREFERENCES. ALL OTHER COMPONENTS REMAIN IN PLACE.

  Patient problems: Joint Laxity

  MAUDE report 22479558 ↗
• InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND STIFFNESS AND THE CAUSE IS UNKNOWN. THE SURGEON DOWNSIZED THE POLY (13 TO 11MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 21585871 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING ARTHROFIBROSIS AND STIFFNESS POST-OP AND THE CAUSE IS UNKNOWN. THE SURGEON DOWNSIZED THE POLY (FROM 13 MM TO 11 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20086504 ↗
• InjuryMay 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 MONTH 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: Medical device site infection

  MAUDE report 19403280 ↗
• InjuryDec 22, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2023. SUBSEQUENTLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. ON (B)(6) 2023, THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT. PRESENTLY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18382645 ↗
• InjuryDec 11, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 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 18301129 ↗
• InjuryAug 19, 2022Adverse Event Without Identified Device or Use Problem

  AT 4 MONTHS AFTER THE PRIMARY, 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: Unspecified Infection

  MAUDE report 15258797 ↗