GMK Sphere Total Knee System 02.12.0414FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07630030826627), received between Feb 20, 2018 and Jun 18, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Unstable” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2025Positioning Problem; Positioning Problem

  AT ABOUT 8 YEARS AND 6 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN AND AN X-RAY REVEALED THAT THE SCREW HAD BACKED OUT OF THE POLY. THE REASON FOR THE LOOSE TIBIA AND THE LOOSE SCREW IS UNKNOWN. THE SURGEON REVISED THE TIBIA AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE TORQUE LIMITER WAS NOT USED DURING PRIMARY SURGERY.

  Patient problems: Pain

  MAUDE report 22269562 ↗
• InjuryAug 10, 2023Adverse 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 DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED SUCCESSFULLY THE LINER.

  Patient problems: Medical device site infection

  MAUDE report 17497131 ↗
• InjuryMar 24, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 1 YEAR AND 11 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16611636 ↗
• InjurySep 29, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2020. ON (B)(6) 2020, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED AN I&D AND POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY. COMPLAINT (B)(4) WAS FILED. PRESENTLY, ON (B)(6) 2021, 8 MONTHS AFTER THE PREVIOUS SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12545490 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 12511784 ↗
• InjurySep 6, 2021Unstable

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE 14MM INSERT WITH A 20MM ONE 9 MONTHS AFTER PRIMARY TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 12427532 ↗
• InjuryMar 4, 2021Unstable; Malposition of Device

  REVISION SURGERY WAS PERFORMED ONE 1 YEAR AND 4 MONTHS AFTER THE PRIMARY SURGERY DUE TO PAIN. THE CAUSE OF THE PAIN WAS A TOO HIGH INSERT WHICH CAUSED LIGAMENTS DAMAGE (THE LIGAMENTS BECOME LAX DUE TO DAMAGE AND A HIGHER INSERT WAS NEEDED) AND RESULTS IN KNEE INSTABILITY. ONLY THE LINER WAS CHANGED. THE SURGEON REVISED 14MM LINER AND IMPLANTED 17MM.

  Patient problems: Joint Laxity

  MAUDE report 11412230 ↗
• InjuryJan 14, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND POLY SWAP, 2 MONTHS AFTER THE PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11168882 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED AFTER 1 YEAR AND 6 MONTHS FROM THE PRIMARY SURGERY DUE TO AN INFECTION. THE SURGEON REVISED THE LINER AND PERFORMED A WASHOUT.

  Patient problems: Unspecified Infection

  MAUDE report 10928253 ↗
• InjuryFeb 21, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN, 5 MONTHS AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8357667 ↗
• InjuryMar 16, 2018Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 7344700 ↗
• InjuryFeb 20, 2018Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE 14MM INSERT FOR A 20MM INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7282459 ↗