MyKnee 4.1013MRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030865855), received between May 17, 2018 and May 17, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2018Inadequacy of Device Shape and/or Size

  AFTER THE PATIENT WAS PUT UNDER ANAESTHESIA, THE AGENT NOTICED THAT THE WRONG MYKNEE BLOCKS WERE IN THE CASE. THE SURGEON RESCHEDULED THE CASE TO A LATER DATE. THE BLOCKS BROUGHT IN ERROR WERE FOR THE SURGERY WITH PATIENT (B)(6) THAT WERE SUPPOSED TO BE FOR THE PATIENT (B)(6) WHO IS SCHEDULED ON (B)(6).

  Patient problems: No Patient Involvement

  MAUDE report 7522293 ↗
• MalfunctionMay 17, 2018Device Operates Differently Than Expected

  THE CUTS ON THE MYKNEE FEMUR BLOCK LEFT THE FEMUR ABOUT 10-15 DEGREES MORE IN VALGUS DESPITE OF THE PLANNED 3 DEGREES. THERE WAS EVEN A NOTICEABLE VALGUS ON THE FEMUR BONE MODEL. THE SURGERY WAS COMPLETED WITH SEVERAL RE CUTS OF THE DISTAL FEMUR AND THE PATIENT WAS LEFT IN 1 DEGREE OF VALGUS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7522285 ↗