GMK Total Knee System 02.12.KA15RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630345716262), received between Jul 1, 2026 and Jul 1, 2026 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2026Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN AND SIGNS OF METAL ALLERGY. THE SURGEON PERFORMED A WASHOUT AND REVISED THE GMK-SPHERIKA S5+R CEMENTED FEMORAL COMPONENT TO A GMK-HINGE FEMORAL COMPONENT SIZE5 R - TINBN COATED, REVISED THE FLEX 5R - 10MM INSERT TO A SIZE5 - 14 MM GMK-HINGE INSERT, AND REVISED THE CEMENTED RIGHT S5 TIBIAL TRAY TO A GMK-HINGE FIXED TINBN COATED TIBIAL TRAY - 5R. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hypersensitivity/Allergic reaction; Implant Pain; Metal Related Pathology

  MAUDE report 25677108 ↗