GMK Sphere Total Knee System 02.12.E0611FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630971262270), received between Aug 4, 2023 and Apr 12, 2024 — classified as 3 injuries.

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.

• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD PATELLAR INSTABILITY AND THE CAUSE IS UNKNOWN. AT ABOUT 3 MONTHS FROM PRIMARY THE SURGEON REVISED THE INSERT WITH A THICKER ONE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19095845 ↗
• InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD PAIN DUE TO THE PATELLA TRACKING BEING OFF. AT 1 MONTH FROM PRIMARY THE SURGEON REVISED THE INSERT BECAUSE HE WAS NOT HAPPY WITH HIS FLEXION GAP AND FOR THE PATELLA HE JUST DID A LATERAL RELEASE OF SOFT TISSUE TO SOLVE THE TRACKING PROBLEM. THE PATELLA WAS NOT REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18214613 ↗
• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 WEEKS 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 17457033 ↗