GMK Revision Total Knee System 02.07.0620SCFRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030819254), received between Oct 23, 2023 and Dec 18, 2025 — classified as 2 injuries.

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.

• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER 2 YEARS AND 8 MONTHS FROM THE PRIMARY PROCEDURE, THE PATIENT PRESENTED WITH PAIN AND INSTABILITY OF UNKNOWN ORIGIN. THE SURGEON UPSIZED THE LINER (FROM 20MM TO 26MM) TO IMPROVE JOINT STABILITY AND RESURFACED THE PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 23838628 ↗
• InjuryOct 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. ABOUT 9 MONTHS FROM THE FIRST REVISION SURGERY, THE SURGEON REVISED THE PATIENT FROM GMK-REVISION TO GMK-HINGE COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT HAD COMPETITOR COMPONENTS PRIOR TO MEDACTA REVISION COMPONENTS.

  Patient problems: Joint Laxity

  MAUDE report 17982989 ↗