GMK Sphere Total Knee System 02.12.E0612FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630971262324), received between Jun 28, 2023 and May 20, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION AFTER ABOUT 1 MONTH FROM PRIMARY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FLEX 6R - 12 MM INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25230412 ↗
• InjuryOct 4, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 MONTH AND A HALF, THE SURGEON PERFORMED A WASHOUT AND POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 20369631 ↗
• InjuryJun 27, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 19621814 ↗
• InjuryJun 27, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY FOR INFECTION, THE PATHOGEN IS UNKNOWN. AT ABOUT 1 MONTH FROM PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 19621812 ↗
• InjuryMar 21, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY PERFORMED DUE TO DISSOCIATION OF THE E-CROSS INLAY FROM THE TIBIAL BASEPLATE 1 YEAR AFTER THE PRIMARY SURGERY. THE INLAY HAS BEEN REVISED.

  Patient problems: Joint Laxity

  MAUDE report 18951463 ↗
• InjuryJun 28, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 5 DAYS FROM PRIMARY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 17215662 ↗