GMK Sphere Total Knee System 02.12.0614FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030827013), received between Aug 23, 2018 and Feb 13, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Unstable” (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.

• InjuryFeb 13, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN FOR A POST-OP APPOINTMENT. IT WAS OBSERVED THAT THE PATIENTS WOUND WAS NOT HEALING. THE SURGEON PERFORMED AN I&D AND POLY-SWAP 18 DAYS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Impaired Healing

  MAUDE report 9705365 ↗
• InjuryJun 13, 2019Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD KNEE PAIN, THE CAUSE IS UNKNOWN. ABOUT 3 YEARS AFTER PRIMARY THE SURGEON RESURFACED THE PATELLA AND REVISED THE 14MM INSERT WITH A 20MM ONE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 8695290 ↗
• InjuryAug 23, 2018Unstable

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY 5 MONTHS AFTER PRIMARY. THE SURGEON SWAPPED A 14 MM POLY FOR A 17 MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Code Available

  MAUDE report 7809076 ↗