MyKnee PPS 8.2013Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030897368), received between Oct 31, 2023 and Oct 31, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Accessory Incompatible” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 31, 2023Accessory Incompatible; Accessory Incompatible

  MYKNEE SURGERY WAS INTENDED TO BE PERFORMED USING METALLIC INSTRUMENT SET INSTEAD OF EFFICIENCY INSTRUMENT SET (NOTE: THE PLANNING WERE INITIALLY CREATED WITH EFFICIENCY SET BUT THEN CHANGED TO METALLIC SET). HOWEVER, THIS INFORMATION DID NOT REACH THE SURGEON CORRECTLY, WHO PERFORMED THE SURGERY USING THE EFFICIENCY SET. THE DISTAL FEMORAL BONE WAS CUT MORE THAN PLANNED, AND A THICKER LINER WAS USED TO COMPENSATE FOR THIS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18037497 ↗