GMK Revision Total Knee System 02.07.2406RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030821479), received between Apr 20, 2021 and Oct 25, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.

• InjuryOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED DUE TO PAIN AND PATELLOFEMORAL OVERLOAD WITH CHRONIC EXTENSION DEFICIT. GMK HINGE WAS IMPLANTED SUCCESSFULLY. EXPLANTS WERE IMPLANTED IN A REVISION SURGERY IN 2012, AFTER UNICONDYLAR IMPLANTATION IN 2008. INLAY EXCHANGE AND PATELLAR RESURFACING WAS PERFORMED IN 2014.

  Patient problems: Implant Pain

  MAUDE report 15665112 ↗
• InjuryApr 20, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  8 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY. THE SURGEON OBSERVED THAT THE PATIENT HAD SOFT TISSUE DAMAGE AND A LOOSE FEMORAL COMPONENT AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY, AND INSERT AND ADDED OFFSET CONNECTORS, FEMORAL WEDGES, FLUTED EXTENSION STEMS AND TIBIAL AUGMENTS. PREVIOUSLY THE PATIENT HAD COMPETITOR IMPLANTS AND WAS REVISED ON (B)(6) 2020 FOLLOWING AN INFECTION, MEDACTA IMPLANTS WERE USED AS AN ANTIBIOTIC SPACER. ON (B)(6) 2020 THE PERMANENT MEDACTA HARDWARE WAS IMPLANTED.

  Patient problems: Pain; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 11692160 ↗