GMK Sphere Total Knee System 02.12.0110FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030825941), received between Aug 2, 2017 and Mar 3, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 11 MONTHS FROM 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: Unspecified Infection

  MAUDE report 21503346 ↗
• InjuryMar 11, 2019Appropriate Device Problem Term/Code Not Available

  INFORMATION RECEIVED ON (B)(6) 2020: ON (B)(6) 2020, THE PATIENT CAME IN AND IS HAVING THE ANTIBIOTIC SPACER EXPLANTED AND IS HAVING NEW HARDWARE IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8408118 ↗
• InjuryAug 2, 2017Migration or Expulsion of Device

  DURING ROUTINE FOLLOW-UP 8 MONTHS AFTER PRIMARY, THE STUDY ASSISTANT NOTICED ON THE PATIENTS X-RAY THAT THE SCREW IN THE INSERT APPEARED TO BE IN THE INCORRECT POSITION. THE X-RAY WAS SENT TO MEDACTA INTERNATIONAL FOR EXAMINATION BY A KNEE BIOENGINEER WHO CONFIRMED (ON (B)(6) 2017) THAT THE SCREW WAS NOT FIXED AND WHILST THE SCREW HAD NOT MIGRATED OUT COMPLETELY WAS DEFINITELY MIGRATING OUT. THE ADVICE GIVEN WAS TO INFORM THE SURGEON AND REMOVE THE SCREW AS SOON AS POSSIBLE BEFORE DAMAGE TO ARTICULATING SURFACES CAN OCCUR. THE PATIENT PRESENTED AT EMERGENCY DEPARTMENT ON (B)(6) WITH PAIN IN HER KNEE AND WAS SENT TO SURGERY WHEN, ON X-RAY, IT WAS NOTICED THE SCREW WAS SITTING IN THE LATERAL POCKET OF THE KNEE. THE SURGEON, USING SCOPE, REMOVED THE SCREW AND IDENTIFIED SMALL SCRATCHES ON, WHAT APPEARS TO BE, A NON ARTICULATING PART OF THE FEMORAL IMPLANT.

  Patient problems: Pain

  MAUDE report 6760053 ↗