GMK Sphere Total Knee System 02.12.0217FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030826252), received between Jul 4, 2018 and May 8, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2019Loose or Intermittent Connection

  THE PATIENT CAME IN, 2 YEARS AFTER PRIMARY SURGERY, COMPLAINING OF INSTABILITY DUE TO LAXITY. THE SURGEON REVISED THE 17MM POLY WITH A 20MM POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8591158 ↗
• InjuryJul 4, 2018Unstable

  WE WERE INFORMED ON (B)(4) 2018 THAT THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE SURGEON BELIEVES THE PATIENT STRETCHED OVER TIME. THE SURGEON PLANS TO REVISE THE POLY ON (B)(6) 2018. ON (B)(6) 2018 WE WERE INFORMED THAT THE SURGEON REVISED THE POLY AND THE TIBIAL COMPONENT ON (B)(6). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7662370 ↗