GMK Sphere Total Knee System 02.12.0517FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030826856), received between Oct 4, 2017 and Mar 15, 2022 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Contamination” (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.

• InjuryMar 15, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY SURGERY ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT CAME REPORTING INSTABILITY DUE TO A FALLING. THE SURGEON REVISED SUCCESSFULLY THE LINER (SIZE 11MM TO 17MM). PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT (SIZE 17MM TO 20MM) AND RESURFACED THE PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 13770425 ↗
• MalfunctionJul 25, 2018Fitting Problem

  DURING THE FINAL IMPLANTATION PROCESS, THE SPHERE POLY WOULD NOT FIT INTO THE TIBIAL BASEPLATE ON THE MEDIAL/POSTERIOR SIDE. A SECONDARY POLY WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7718466 ↗
• InjuryMay 18, 2018Contamination

  REVISION SURGERY PERFORMED DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE POLY.

  Patient problems: Unspecified Infection

  MAUDE report 7525814 ↗
• InjuryOct 13, 2017Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I & D AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 6947207 ↗
• InjuryOct 4, 2017Device Operates Differently Than Expected; Appropriate Device Problem Term/Code Not Available

  THE PATIENT FELL AND CAME IN DUE TO SIGNS OF INFECTION. ALSO, THE INCISION BROKE. THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I AND D AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 6913756 ↗