GMK Sphere Total Knee System 02.12.0213FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630030862557), received between Jul 20, 2017 and Nov 7, 2023 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT 6 WEEKS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND THE CAUSE OF THE LAXITY IS UNKNOWN. THE SURGEON REVISED THE INSERT (FROM 13 TO 17 MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18083885 ↗
• InjuryOct 18, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT 3 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 17955597 ↗
• InjuryApr 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 1 MONTH AFTER THE PRIMARY, REVISION SURGERY PERFORMED DUE TO KNEE INSTABILITY. THE SURGEON REVISED THE LINER (13 TO 17 MM) AND RESURFACED THE NATURAL PATELLA.

  Patient problems: Joint Laxity

  MAUDE report 16673076 ↗
• InjuryJul 2, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED DUE TO INFECTION 1 YEAR AND 8 MONTHS AFTER THE PRIMARY SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 12106182 ↗
• InjurySep 22, 2017Material Erosion; Device Markings/Labelling Problem

  KNEE REVISION DUE TO PAIN AND REDUCED KNEE FLEXION 7 MONTHS AFTER PRIMARY RTKR. FEMORAL LIFT OFF ON MEDIAL SIDE AT ABOUT 90° FLEXION. UPON REMOVAL OF 13MM POLY INSERT THERE APPEARED TO BE YELLOW MARKINGS ON INSERT SUGGESTING OXIDISATION OF POLYETHYLENE INSERT. LIKELY POOR FLEXION POST-OP DUE TO NOT ENOUGH POSTERIOR SLOPE APPLIED TO TIBIA. ROM IMPROVED WITH SCAR RELEASES AND TISSUE RELEASES. POLY INSERT DOWNSIZED TO 12MM.

  Patient problems: Pain

  MAUDE report 6886396 ↗
• InjuryJul 20, 2017Loose or Intermittent Connection

  LOOSE TIBIAL INSERT SCREW FLOATING IN THE KNEE JOINT. THE SURGEON PLANNED TO REMOVE SCREW ARTHROSCOPICALLY AND ASSESS INSERT VIABILITY, IF NECESSARY SURGEON WILL OPEN UP AND EXCHANGE THE TIBIAL INSERT. THE SURGEON COMMENTED THAT THIS INSERT SCREW WAS IMPLANTED PRIOR TO THE INTRODUCTION OF THE TORQUE LIMITING SCREW DRIVER AND HE FEELS THAT HE TIGHTEN THE TIBIAL INSERT SCREW TIGHTER NOW THAT HE HAS THIS AVAILABLE. ISSUE DETECTED DURING ROUTINE FOLLOW UP X-RAY BY SURGEON. AT REVISION THE SURGEON REMOVED THE SCREW ARTHROSCOPICALLY, ALL REMAINING COMPONENTS WHERE FINE. THE SURGEON WAS VERY HAPPY WITH THE OUTCOME.

  Patient problems: No Code Available

  MAUDE report 6727740 ↗