GMK Sphere Total Knee System 02.12.0410CRLRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630040707473), received between Apr 30, 2021 and Dec 5, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 MONTHS FROM PRIMARY THE SURGEON REVISED ALLA COMPONENTS DUE TO AN INFECTION AND SUBSEQUENT INSTABILITY. HINGE IMPLANTS HAVE BEEN IMPLANTED AND SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 20851310 ↗
• InjuryAug 19, 2022Device Dislodged or Dislocated

  THE PATIENT CAME IN REPORTING PAIN DUE TO A PATELLA BONE DISLOCATION AND THE CAUSE IS UNKNOWN. THE SURGEON RELEASED THE PCL, REVISED THE POLY, AND DID A LATERAL RELEASE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 15258877 ↗
• InjuryOct 25, 2021Appropriate Device Problem Term/Code Not Available

  AT 9 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12688140 ↗
• InjuryJul 21, 2021Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Unspecified Infection

  MAUDE report 12202386 ↗
• InjuryApr 30, 2021Naturally Worn

  REVISION SURGERY FOLLOWING LINER WEAR 2 WEEKS AFTER PRIMARY. DURING SURGERY IT WAS NOTICED THAT THE FEMORAL COMPONENT DID NOT SHOW ANY DAMAGE, ONLY THE INLAY WAS WORN ON BOTH SIDES.

  Patient problems: Unspecified Infection

  MAUDE report 11752485 ↗