GMK Sphere Total Knee System 02.12.E0512FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07630971262089), received between Apr 3, 2023 and Feb 16, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (6 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.

• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN AND LIMITED RANGE OF EXTENSION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT FROM A 12MM TO A 10MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Loss of Range of Motion

  MAUDE report 24343895 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE POLY FROM A 12MM TO A 20MM TO IMPROVE PATIENT STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24068443 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING ANTERIOR KNEE PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON RESURFACED THE PATIENT'S NATURAL PATELLA AND UPSIZED THE LINER TO GIVE THE PATIENT MORE STABILITY (FROM 12 TO 14 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 23725623 ↗
• InjuryOct 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 YEAR AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23299597 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 3 MONTHS POST-PRIMARY, THE PATIENT REPORTED INSTABILITY OF UNKNOWN ORIGIN. THE SURGEON REVISED THE INSERT FROM 12 MM TO 13 MM TO RESTORE JOINT STABILITY. SURGERY COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22673492 ↗
• InjuryFeb 3, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 10 MONTHS FROM 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 21291099 ↗
• InjuryOct 22, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 2 WEEKS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 20506567 ↗
• InjuryOct 4, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 WEEKS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PREFORMED A WASHOUT AND POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection; Unspecified Infection

  MAUDE report 20366839 ↗
• InjuryJun 13, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2024. ON (B)(6) 2024, 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. ON (B)(6) 2024, 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 19527586 ↗
• InjuryApr 3, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH AND 1 WEEK AFTER THE PRIMARY SURGERY, 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.

  Patient problems: Medical device site infection

  MAUDE report 16664348 ↗