GMK Total Knee System 02.12.KA14RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630345716248), received between Mar 13, 2025 and Mar 3, 2026 — classified as 2 injuries.

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 16, 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.

• InjuryMar 3, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 1 YEAR FROM THE PRIMARY, THE PATIENT CAME IN DUE TO A LOOSE FEMORAL IMPLANT AND THE CAUSE IS UNKNOWN. THE SURGEON NOTED THAT THE BONE QUALITY WAS GOOD AND THERE WERE NO SIGNS OF INFECTION. ADDITIONALLY, THERE WAS NO REPORTED TRAUMA. THE SURGEON REVISED THE MEDACTA TIBIAL TRAY, INSERT, AND FEMORAL COMPONENT TO A COMPETITOR TRAY, INSERT, AND FEMORAL COMPONENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 24494900 ↗
• InjuryMar 13, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AT ABOUT 6 MONTHS FROM THE MEDACTA PRIMARY SURGERY AND THE SURGEON OBSERVED THAT AN IMPLANT IS FAILING. SEVERAL INFECTIONS REPORTED DURING THE RECOVERY. THERE IS NO OTHER INFORMATION AVAILABLE AT THIS TIME. PRIMARY SURGERY OF COMPETITORS. A REVISION HAS NOT BEEN SCHEDULED AT THIS TIME. MEDWATCH (MW5166553) REPORT WAS SUBMITTED TO FDA BY THE PATIENT. DESCRIPTION REPORTED IN THE FDA REPORT: RECENTLY HAD A SECOND TOTAL KNEE REVISION ON (B)(6) 2024 THE RECOVERY HAS BEEN SEVERAL INFECTIONS ONLY TO FIND OUT (B)(6) 2025 BY ORTHOPEDIC DOCTOR THE PART IS FAILING (PART NAME MEDECTA.).

  Patient problems: Medical device site infection

  MAUDE report 21594484 ↗