GMK Sphere Total Knee System 02.12.E0212FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630971261358), received between Jul 22, 2024 and Jun 26, 2026 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING TIGHTNESS AND THE CAUSE IS UNKNOWN. THERE WAS NO INDICATION OF TRAUMA. THE SURGEON REMOVED THE SCAR TISSUE. THE RESULTING INCREASE IN JOINT SPACE REQUIRED UPSIZING THE POLYETHYLENE INSERT FROM 12 MM TO 14 MM IN ORDER TO RESTORE APPROPRIATE SOFT-TISSUE BALANCE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 25632988 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY AFTER 1 YEAR AND 6 MONTHS POST PRIMARY DUE TO ANTERIOR KNEE PAIN AND KNEE INSTABILITY. THE SURGEON REVISED THE PATIENT`S NATURAL PATELLA AND REVISED THE INSERT FROM 12MM TO 14MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 24321122 ↗
• InjuryDec 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. THE SURGEON REVISED THE 12MM INSERT WITH A 17MM INSERT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23858481 ↗
• InjuryNov 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH FROM PRIMARY, THE PATIENT CAME IN DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23669508 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 5 MONTHS, THE PATIENT CAME IN REPORTING STIFFNESS. THE SURGEON DOWNSIZED THE INSERT (FROM 12 TO 10 MM) TO GIVE THE PATIENT MORE RANGE OF MOTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Loss of Range of Motion

  MAUDE report 22936837 ↗
• InjuryJul 22, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 12 DAYS 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: Medical device site infection

  MAUDE report 19790036 ↗