GMK Sphere Total Knee System 02.12.0317FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030826450), received between Sep 16, 2020 and Aug 26, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 9 YEARS 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 20062235 ↗
• InjuryDec 18, 2020Break; Break

  DURING A FOLLOW-UP VISIT, IT WAS DISCOVERED THAT THE INLAY LOCKING SCREW IS UNSCREWED, AND FREE INTO THE JOINT. AFTER A MORE SPECIFIC ANALYSIS, THE SCREW RESULTS TO BE BROKEN. THERE IS NO PLAN TO REVISE THE PATIENT, AT THE MOMENT, NOR TO REMOVE THE PART OF THE SCREW.

  Patient problems: Insufficient Information

  MAUDE report 11036712 ↗
• InjurySep 16, 2020Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Unspecified Infection

  MAUDE report 10539664 ↗