GMK Sphere Total Knee System 02.12.0610FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07630030826948), received between May 9, 2018 and Dec 2, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 4 YEARS FROM THE 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 23690781 ↗
• InjurySep 2, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 1 YEAR AND 8 MONTHS FROM HTE 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 20118005 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 10 MONTHS AFTER PRIMARY SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (12MM) WITH A THICKER ONE (14MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 16415659 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED 1 YEAR 5 MONTHS AFTER THE PRIMARY SURGERY DUE TO KNEE INSTABILITY. THE SURGEON REVISED THE LINER (10 TO 13 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 16415633 ↗
• InjuryJan 31, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 6 YEARS 8 MONTHS 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 POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 16271688 ↗
• InjuryOct 27, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 1 YEAR AND 9 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE INSERT (10 MM) WITH A THICKER ONE (12MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 15679059 ↗
• InjuryAug 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 WEEKS FROM 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. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 15273677 ↗
• InjuryJan 24, 2022Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Unspecified Infection

  MAUDE report 13333122 ↗
• InjuryJan 4, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN 1 YEAR AND 4 MONTHS AFTER THE PRIMARY SURGERY REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE INSERT (10MM TO 12MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 13152886 ↗
• InjuryJul 26, 2018Loose or Intermittent Connection

  DURING A STANDARD FOLLOW-UP CHECK IN THE HOSPITAL, THE SURGEON DETECTED THE LOOSE TIBIAL INSERT FIXATION SCREW IN THE BACK OF THE JOINT ON THE CORRESPONDING X-RAY PICTURES. A TORQUE-LIMITER SCREWDRIVER WAS NOT AVAILABLE AT THE DATE OF THE PRIMARY SURGERY. CURRENTLY WE HAVE NO FURTHER INFORMATION ABOUT THE NEXT STEP IN TERMS OF REVISION SURGERY DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7722400 ↗
• InjuryMay 9, 2018Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO EARLY SIGNS OF INFECTION 10 DAYS AFTER PRIMARY. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE POLY. THE PATHOGEN IS UNAVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 7498749 ↗