GMK Sphere Total Knee System 02.12.0313FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030862595), received between May 27, 2019 and May 5, 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.

• InjuryMay 5, 2026Device Appears to Trigger Rejection

  AT ABOUT 3 YEARS AND 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE 13MM INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25077217 ↗
• InjuryMay 15, 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 IS UNKNOWN. ABOUT 8 YEARS AND 6 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE LINER WITH A THICKER ONE (FROM 13 TO 20 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22027485 ↗
• InjuryMay 4, 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 ABOUT 2 YEARS FROM PRIMARY SURGERY THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 16866662 ↗
• InjuryMar 2, 2022Unstable

  THE PATIENT CAME IN REPORTING INSTABILITY. THE SURGEON REVISED THE INSERT WITH A THICKER ONE (17 MM) AND PATELLA 2 YEARS AND 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 13652369 ↗
• InjuryFeb 6, 2020Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN, 1 YEAR AND 4 MONTHS AFTER PRIMARY SURGERY, REPORTING ANTERIOR KNEE PAIN. THE CAUSE OF THE ANTERIOR KNEE PAIN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND REVISED THE PATELLA AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 9676089 ↗
• InjuryMay 27, 2019Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN COMPLAINING OF ANTERIOR KNEE PAIN AND THE CAUSE OF PAIN IS UNKNOWN. THE SURGEON RESURFACED THE PATELLA AND REVISED THE POLY 2 MONTHS AFTER PRIMARY.

  Patient problems: Pain

  MAUDE report 8644139 ↗