GMK Total Knee System 02.12.KA05RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630345716125), received between Mar 17, 2025 and Jul 16, 2026 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 16, 2026Device Appears to Trigger Rejection

  THE PATIENT HAD KNEE INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 2 MONTHS POST PRIMARY SURGERY THE SURGEON PERFORMED A WASHOUT AND REVISED THE FEMORAL COMPONENT, INSERT, AND TIBIAL TRAY INSERTING ANTIBIOTIC SPACERS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25838710 ↗
• MalfunctionMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADVERSE EVENT DURING CLINICAL STUDY. AT ABOUT 1 MONTH AND A HALF FROM PRIMARY SURGERY, THE SURGEON TREATED THE PATIENT FOR RIGIDITY AND STIFFNESS OF THE KNEE UNDER ANESTHESIA.

  Patient problems: Loss of Range of Motion

  MAUDE report 21618032 ↗