GMK Sphere Total Knee System 02.12.E0314FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07630971261686), received between Aug 26, 2024 and Mar 30, 2026 — classified as 5 injuries, 1 malfunction.

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.

• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY DUE TO KNEE INSTABILITY ABOUT 1 YEAR AND 5 MONTHS AFTER PRIMARY SURGERY AND THE CAUSE IS UNKNOWN. THERE WAS NO TRAUMA REPORTED. THE SURGEON UPSIZED THE 14MM INSERT TO A 17MM INSERT TO ADDRESS THE INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 24711041 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN AS THE RESULT OF A PATELLA TENDON RUPTURE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT FROM A 14MM TO A 17MM DUE TO INSTABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Damage to Ligament(s); Joint Laxity

  MAUDE report 24376299 ↗
• MalfunctionNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON WOULD LIKE TO UPSIZE THE POLY (FROM 14 MM TO 15 OR 16 MM) TO GIVE THE PATIENT MORE STABILITY. A COMPASSIONATE USE CASE IS BEING INITIATED TO REQUEST THESE CUSTOM SIZE INSERTS FOR THE PATIENT. A SURGERY HAS NOT BEEN SCHEDULED AT THIS TIME. MORE DETAILS TO FOLLOW ONCE THE SURGERY IS COMPLETE.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 23583091 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR 1 MONTH AFTER THE PRIMARY, THE PATIENT REPORTED SOME INSTABILITY IN R KNEE. THE SURGEON MADE DECISION TO UPSIZE THE POLY TO ACHIEVE GREATER STABILITY (14 TO 20 MM).

  Patient problems: Joint Laxity

  MAUDE report 22060082 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 6 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND STIFFNESS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER (14MM) WITH A THINNER ONE (10MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Loss of Range of Motion

  MAUDE report 21642960 ↗
• InjuryAug 26, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 3 MONTHS AFTER 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: Medical device site infection

  MAUDE report 20062378 ↗