GMK Sphere Total Knee System 02.12.0210CRLRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630040707190), received between Nov 30, 2021 and Mar 2, 2026 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS 10 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO LIMITED RANGE OF MOTION AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A SYNOVECTOMY AND REVISED THE PATIENT`S NATURAL PATELLA AND UPSIZED THE INSERT FROM 10MM TO 12MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 24482227 ↗
• InjuryJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Medical device site infection

  MAUDE report 17387662 ↗
• InjuryMar 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS 4 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (10 TO 17 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 16590953 ↗
• InjuryFeb 21, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. AT 1 YEAR AND 7 MONTHS FROM THE PRIMARY THE SURGEON REVISED THE INSERT WITH A 13MM ONE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 13567432 ↗
• InjuryNov 30, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. AT 2 YEARS AND 6 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE INSERT WITH A HIGHER ONE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 12890279 ↗