GMK Revision Total Knee System 02.07.FCL12065Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030822902), received between Oct 11, 2019 and Oct 11, 2019 — classified as 1 injury.

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

• InjuryOct 11, 2019Fracture; Fracture

  THE SCREW WHICH FIXES THE OFFSET TO THE FEMUR IS LOST (UNSCREWED), VISIBLE AT THE RX. THE PATIENT HAD TO UNDERGO TO A REVISION SURGERY ALMOST 3 MONTHS AFTER PRIMARY. THE SURGEON WAS NOT ABLE TO LOCATE THE SCREW SO HE LEFT IT IN THE PATIENT, HE THEN REPLACED THE INLAY WITH A BIGGER ONE AND PLACED A NEW SCREW IN THE FEMUR WITH THE CORRECT TORQUE LIMITER SCREWDRIVER." THE CORRECT PRIMARY DATE TO BE REPORTED, IS (B)(6) 2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9178277 ↗