GMK Revision Total Knee System 02.07.0112SCFRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030816017), received between Feb 19, 2020 and Sep 6, 2023 — 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.

• InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. AT 3 YEARS AND 8 MONTHS POST OPERATIVE THE SURGEON REVISED THE 12MM POLY WITH A 17MM POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17689782 ↗
• InjuryFeb 19, 2020Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. THE CAUSE OF THE LAXITY IS UNKNOWN. 10 MONTHS AFTER PRIMARY SURGERY, THE SURGEON REVISED THE MEDACTA INSERT SEMICONSTRAINED 12MM S1 WITH A MEDACTA INSERT SEMICONSTRAINED 17MM S1. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9726775 ↗