GMK Sphere Total Knee System 02.12.E0213FLRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630971261396), received between Feb 18, 2026 and Apr 9, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO INFECTION ABOUT 1 MONTH AFTER PRIMARY SURGERY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE 13MM INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24826098 ↗
• InjuryMar 16, 2026Device Dislodged or Dislocated

  ABOUT 4 MONTHS AFTER THE PREVIOUS REVISION SURGERY, THE PATIENT CAME IN PRESENTING PAIN DUE TO DISSOCIATION OF THE LINER FROM THE TIBIAL TRAY. THE SURGEON REVISED THE LINER TO THE SAME SIZE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD PRIMARY KNEE SURGERY ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT CAME IN DUE TO ANTERIOR KNEE PAIN DUE TO THE PATELLA WAS SUBLUXING OR POSSIBLY DISLOCATING IN EXTENSION. THE SURGEON NOTED THAT THE PATELLA WOULD FLEX LATERALLY, THEN SEEM TO TRACK NORMALLY. THE SURGEON PERFORMED A LATERAL RELEASE OF THE PATELLA TENDON. THE SURGEON THEN PERFORMED A WASHOUT AND POLY SWAP PER STANDARD PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY. EVENT RELATED ASLO TO MDR 2025-01134.

  Patient problems: Joint Dislocation

  MAUDE report 24603549 ↗
• InjuryFeb 18, 2026Device Appears to Trigger Rejection

  AT 2 YEARS 7 MONTHSFROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND UPSIZED THE POLY FROM A 13MM TO A 14MM AT THE SURGEON`S DISCRETION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 24376294 ↗