GMK Revision Total Knee System 02.07.0520SCFRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030818677), received between Dec 20, 2018 and Apr 9, 2026 — 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.

• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  AT 4 YEARS 4 MONTHS FROM MEDACTA PRIMARY SURGERY, THE PATIENT CAME IN DUE TO INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON OBSERVED THAT THE BONE/TISSUE QUALITY WAS POOR. THE SURGEON REVISED THE SEMICONSTRAINED 20MM S5 INSERT TO A SEMICONSTRAINED 23MM S5 INSERT AND REVISED THE TINBN COATED 20MM PEG TO A TINBN COATED 23MM PEG. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 24826095 ↗
• InjuryMay 13, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 3 YEARS 7 MONTHS FROM PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 22009956 ↗
• InjuryDec 20, 2018Appropriate Device Problem Term/Code Not Available

  ABOUT 3 YEARS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR KNEE INFECTION. I&D AND INSERT SWAP PERFORMED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8184573 ↗