GMK Revision Total Knee System 02.07.0420SCFRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030818097), received between Apr 13, 2021 and Dec 20, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 4 MONTHS AND 2 WEEKS AFTER THE FIRST REVISION SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. COMPETITOR COMPONENTS WERE IMPLANTED DURING THE PRIMARY SURGERY AND IN THE FIRST REVISION SURGERY THE PATIENT WAS REVISED TO MEDACTA REVISION COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 16015099 ↗
• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD PRIMARY KNEE SURGERY ON (B)(6) 2012 AND HAD THE TOTAL KNEE IMPLANTED AROUND A NAIL. ON (B)(6) 2021, THE SURGEON REMOVED THE FEMORAL COMPONENT AND POLY TO REMOVE THE NAIL. ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY. PRESENTLY, ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12370172 ↗
• InjuryApr 13, 2021Appropriate Device Problem Term/Code Not Available

  5 MONTHS AFTER THE PRIMARY SURGERY A REVISION SURGERY AND DIAR (DEBRIDEMENT, ANTIBIOTICS, IRRIGATION, AND RETENTION) WERE PERFORMED DUE TO SUSPECTED ACUTE INFECTION. THE INSERT WAS REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 11654725 ↗