GMK Sphere Total Knee System 02.12.0212CRRRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630040707244), received between Feb 3, 2021 and Nov 25, 2024 — 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.

• InjuryNov 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 1 YEAR AND 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A (POSTERIOR CRUCIATE LIGAMENT) PCL TEAR AND INSTABILITY, AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE POLY WITH A THICKER ONE (FROM 12 TO 17 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Damage to Ligament(s)

  MAUDE report 20771233 ↗
• InjuryNov 24, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY 1 YEAR AND 9 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON REVISED THE LINER WITH A THICKER ONE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 15860282 ↗
• InjuryOct 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR AND 11 MONTHS POST PRIMARY REVISION SURGERY FOR KNEE LAXITY. THE SURGEON IMPLANTED A MORE CONSTRAINED LINER SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 15550789 ↗
• InjuryFeb 12, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY 10 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11320658 ↗
• InjuryFeb 3, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN AND SWELLING IN THE KNEE 7 MONTHS AFTER THE PRIMARY. INFECTION EXCLUDED, THE CAUSE OF THE PAIN AND SWELLING IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Swelling/ Edema

  MAUDE report 11271429 ↗