GMK Sphere Total Knee System 02.12.E0211FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07630971261327), received between Dec 15, 2023 and Aug 3, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Device Appears to Trigger Rejection

  Revision surgery after 1 year and 2 months from the primary due to infection.The surgeon performed a washout and revised the poly. The surgery was completed successfully.

  Patient problems: Medical device site infection

  MAUDE report 50114137 ↗
• InjuryDec 9, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2024. ON (B)(6) 2025, THE PATIENT IN DUE TO SIGNS OF AN INFECTION. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY ((B)(4)). PRESENTLY, ON (B)(6) 2025, THE PATIENT IN DUE TO SIGNS OF AN INFECTION. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23758554 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. AT ABOUT 1 YEAR AND 4 MONTHS POST PRIMARY THE SURGEON UPSIZED THE POLY FROM 11MM TO 14MM FOR STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23461653 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 10 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO INSTABILITY WITH AN UNKNOWN CAUSE. THE SURGEON REVISED THE INSERT FROM AN 11MM TO A 14MM SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23093858 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. ABOUT 1 YEAR AFTER THE PRIMARY SURGERY, THE SURGEON UPSIZED (FROM 11 TO 14) THE INSERT TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22901808 ↗
• InjuryAug 20, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 5 MONTHS 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 22849201 ↗
• InjuryMay 30, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 MONTHS 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.

  Patient problems: Medical device site infection

  MAUDE report 22114072 ↗
• InjuryMay 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT UNDERWENT REVISION AT ABOUT 1 WEEK FROM PRIMARY AFTER REPORTING PAIN DUE TO DISLOCATING HER LEG WHILE STILL IN THE HOSPITAL FROM THE PRIMARY SURGERY. THE SURGEON REVISED ALL COMPONENTS TO HINGE COMPONENTS. SEVERE LIGAMENT LAXITY WAS REPORTED AND POSTERIOR CAPSULE WAS COMPROMISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22008320 ↗
• InjuryApr 30, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 WEEKS 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 21932361 ↗
• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 4 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (11 TO 14MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 21523851 ↗
• InjuryJan 29, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 10 DAYS 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 21261901 ↗
• InjuryNov 7, 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 STIFFNESS DUE TO LACK OF RANGE OF MOTION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (FROM 11 TO 10 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 20630434 ↗
• InjuryMar 28, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION DUE TO AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 18 DAYS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 18991246 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THEIR NATIVE PATELLA AND STIFFNESS. THE SURGEON RESURFACED THE NATURAL PATELLA AND REVISED THE INSERT (11 MM TO 10 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 18333496 ↗