GMK Revision Total Knee System 02.07.FCL11065Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030822872), received between Oct 25, 2017 and Sep 11, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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.

• InjurySep 11, 2019Fracture; Appropriate Device Problem Term/Code Not Available

  THE GMK HINGE WAS IMPLANTED IN THE PATIENT ON (B)(6) 2016 REVISING A SYSTEM OF COMPETITOR. IN AN UNKNOWN DATE THE PATIENT HAD A PERI-PROSTHETIC FRACTURE AT STEM FEMUR LEVEL AND WAS OPERATED TO CABLE THE FEMUR AND TO INSERT A PLATE TO FIX THE BONE FRACTURE. 3 YEARS AFTER GMK HINGE IMPLANTATION THE PATIENT HAD A NEW AT PERI-PROSTHETIC FRACTURE AT FEMUR STEM LEVEL. THE SURGEON REVISED ALL THE FEMORAL COMPONENTS IMPLANTING A LONGER FEMUR STEM AND NEW FEMORAL COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 8992822 ↗
• InjuryOct 25, 2017Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON PERFORMED AN I&D AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 6975544 ↗