GMK Sphere Total Knee System 02.12.0026LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030862434), received between Nov 25, 2020 and Dec 27, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 reports).

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.

• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 4 YEARS AND 5 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMUR AND THE PATELLA WAS NOT TRACKING WELL. THE SURGEON REVISED THE FEMUR, POLY AND PATELLA. THE LINER WAS UPSIZED FROM 12MM TO 13MM TO ACCOMMODATE LIGAMENT LAXITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Joint Laxity

  MAUDE report 21026667 ↗
• InjuryDec 6, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT 4 YEARS AND 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO A LOOSE TIBIAL TRAY AND FEMORAL COMPONENT. THE SURGEON REVISED THE TIBIAL TRAY, INSERT AND FEMORAL COMPONENT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18272461 ↗
• InjuryNov 25, 2020Unstable

  REVISION SURGERY PERFORMED AFTER 1 YEAR AND 10 MONTHS FROM THE PRIMARY SURGERY DUE TO INSTABILITY. THE KNEE BECOMES UNSTABLE AFTER THE THERAPIST MANIPULATED THE KNEE INTO EXTENSION. IT APPEARS TO BE SOFT-TISSUE RELATED AS POP WAS FELT. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY, AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 10905589 ↗