GMK Sphere Total Knee System 02.12.0317FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030826467), received between Jul 31, 2018 and Oct 30, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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.

• MalfunctionOct 30, 2025Use of Device Problem; Use of Device Problem

  TIBIAL INSERT FLEX (STANDARD PE) COULD NOT BE CLIPPED INTO THE TIBIAL TRAY. AS NO BACK-UP WAS AVAILABLE (ONLY 14 AND 20 MM WAS AVAILABLE), THE SURGEON USED A CLEAN BLADE TO SLIGHTLY TRIM OFF MATERIAL FROM THE INSERT WHERE IMPINGEMENT WAS PERCEIVED AND WAS ABLE TO PLACE THE INSERT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23425360 ↗
• InjuryApr 13, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN 3 YEARS 3 MONTHS AFTER THE PRIMARY REPORTING INSTABILITY DUE TO LAXITY. THE CAUSE OF THE LAXITY IS UNKNOWN. THE SURGEON REVISED THE POLY WITH A HIGHER ONE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 11654476 ↗
• InjuryJul 28, 2020Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. THE SURGEON REVISED THE MEDACTA GMK-SPHERE TIBIAL INSERT - FLEX S3R - 17 MM WITH A MEDACTA GMK-SPHERE TIBIAL INSERT - FLEX S3R - 20 MM 2 YEARS AND 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 10331235 ↗
• InjuryJul 31, 2018Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THAT THE PATELLA IS SUBLUXING. THE SURGEON REVISED THE INSERT AND RELEASED THE PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7734720 ↗