MyKnee 6.1025SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030894787), received between Apr 30, 2021 and Apr 30, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2021Malposition of Device

  DURING THE SURGERY, IT WAS OBSERVED THAT THE CUTTING GUIDE WAS DIFFERENT FROM THE GRAPHIC DESIGN SENT TO THE SURGEON PRE-SURGERY. THE SURGEON HAD TO USE TRADITIONAL INSTRUMENTS TO CUT THE DISTAL FEMUR. THERE WAS A 1-HOUR AND 30-MINUTE DELAY AND ADDITIONAL ANAESTHESIA HAD TO BE ADMINISTERED TO THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE IMAGES RECEIVED BY MYSOLUTION DEPARTMENT SHOWS RED AND GREEN DOTS WHERE THE PINS SHOULD BE INSERTED, AND THE CUTTING GUIDE WAS SUPPOSED TO BE FIXED TO THE BONE WITH PINS INSERTED IN THE GREEN DOTS. HOWEVER, THE CUTTING GUIDE INSTRUMENT PROVIDED DID NOT SEEM TO MATCH THE PLAN. THE SURGEON HAD TO DISREGARD THE MYKNEE PLAN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant

  MAUDE report 11753004 ↗