GMK Revision Total Knee System 02.07.0683LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030819360), received between Aug 29, 2019 and Jul 25, 2024 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD SHIN PAIN AND THE CAUSE WAS UNKNOWN. AT ABOUT 1 YEAR AND 1 MONTH POST PRIMARY THE SURGEON REVISED THE TIBIAL TRAY, INSERT, AUGMENTS AND EXTENSION STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY. NOTES: PATIENT EXPRESSED SHIN PAIN FROM THE 11X150 STEM EXTENSION. THE ORIGINAL TIBIAL COMPONENT WITH TIBIAL AUGMENTS, AND STEM EXTENSION WERE REMOVED. A SHORT STEM EXTENSION WAS UTILIZED WITH ORIGINAL SIZE AUGMENTS WAS USED.

  Patient problems: Pain

  MAUDE report 19826861 ↗
• InjuryMar 21, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 5 YEARS AND 5 MONTHS AFTER THE SYSTEM HAS BEEN IMPLANTED, THE PATIENT CAME IN REPORTING PAIN DUE TO TIBIAL TRAY LOOSENING AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE TIBIAL TRAY AND INSERT. THE PATIENT WAS PREVIOUSLY REVISED FROM COMPETITOR TO MEDACTA IMPLANTS.

  Patient problems: Insufficient Information

  MAUDE report 16583851 ↗
• InjuryAug 29, 2019Appropriate Device Problem Term/Code Not Available

  ON (B)(4) 2019 WE RECEIVED THE INFORMATION OF A REVISION SURGERY, THAT WAS THEN PERFORMED ON (B)(6) 2019, DUE TO SIGNS OF AN INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON REMOVED ALL IMPLANTS FROM THE PATIENT AND IMPLANTED AN ANTIBIOTIC SPACER SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8945082 ↗