GMK Sphere Total Knee System 02.12.0021RRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030862458), received between Sep 4, 2019 and May 22, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY DUE TO KNEE LUXATION (FEMORAL COMPONENT FROM THE LINER), AT ABOUT 1 MONTH AFTER PRIMARY. THE PATIENT HAD A DOMESTIC INCIDENT AND DURING REHABILITATION THE FEMORAL COMPONENT DISLOCATED. THE SURGEON REVISED ALL COMPONENTS TO HINGE COMPONENTS.

  Patient problems: Joint Dislocation

  MAUDE report 19371341 ↗
• InjuryNov 22, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY DUE TO KNEE INSTABILITY AND LOOSENING OF TIBIAL AND FEMORAL COMPONENTS, AT ABOUT 4 YEARS 9 MONTHS FROM THE PRIMARY. ALL COMPONENTS REVISED SUCCESSFULLY TO HINGE SYSTEM.

  Patient problems: Joint Laxity

  MAUDE report 18190074 ↗
• InjurySep 22, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO DEVELOPING A MEDIAL COLLATERAL LIGAMENT RUPTURE. THE CAUSE OF THE RUPTURE IS UNKNOWN. 11 MONTHS AFTER PRIMARY THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY, AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Rupture

  MAUDE report 10567153 ↗
• InjurySep 4, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED AFTER 2 YEARS AND 2 MONTHS FROM THE PRIMARY DUE TO PAIN AND THE CAUSE OF PAIN IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY AND INSERT (10 MM EXCHANGED WITH LINER 17 MM) SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 8959262 ↗