GMK Sphere Total Knee System 02.12.0412CRRRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630040707527), received between Jul 5, 2023 and Aug 8, 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.

• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY RIGHT TKA ON (B)(6) 2019 AND HAD A PRIMARY LEFT TKA ON (B)(6) 2019. PRESENTLY ON (B)(6) 2024 THE PATIENT CAME IN REPORTING INSTABILITY. THE SURGEON PERFORMED A BILATERAL POLY-SWAP, REVISING THE RIGHT S4 12MM SPHERE CR TO A S4 14MM SPHERE E-CROSS AND THE LEFT S4 11MM SPHERE CR TO A S4 14MM SPHERE E-CROSS. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO PROBLEMS WERE REPORTED WITH ANY OF THE DEVICES.

  Patient problems: Joint Laxity

  MAUDE report 19936760 ↗
• InjuryMar 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 1 YEAR AND 5 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE INSERT (FROM 12 MM TO 17 MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18866084 ↗
• InjuryJul 5, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 2 YEARS 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO KNEE INSTABILITY AND LOOSE PATELLA AND THE CAUSE OF THE INSTABILITY AND LOOSE PATELLA IS UNKNOWN. THE SURGEON REVISED THE PATELLA AND INSERT (12MM TO 17MM). THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17258642 ↗