GMK Sphere Total Knee System 02.12.0314FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030826429), received between May 25, 2018 and Jun 25, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  AT ABOUT 11 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER (14MM) WITH A THICKER ONE (17MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 19603809 ↗
• InjuryJun 21, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  AT 3 YEARS AND 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND THE CAUSE OF THE LAXITY IS UNKNOWN. THE SURGEON REVISED THE INSERT (14MM TO 20MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 14751542 ↗
• InjuryNov 6, 2018Device Dislodged or Dislocated

  THE PATIENT CAME IN COMPLAINING OF PAIN 2 YEARS AND 2 MONTHS AFTER PRIMARY. THE SURGEON DETERMINED THAT THE POLY SCREW HAD BACKED OUT. THE SURGEON REMOVED THE SCREW THROUGH ARTHROSCOPY. THE LINER WAS NOT EXCHANGED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE TORQUE HANDLE SCREWDRIVER WAS NOT USED IN PRIMARY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 8041538 ↗
• InjuryMay 25, 2018Unstable

  TEN DAYS AFTER PRIMARY CASE (SEE MDR 2018-00336) THE PATIENT WAS REVISED BECAUSE THE FEMUR WAS TOO IN VALGUS AND THE PATIENT KNEE WAS UNSTABLE. ONLY POLY SWAP PERFORMED SUCCESSFULLY.

  Patient problems: No Code Available

  MAUDE report 7544748 ↗