Knee Instruments 02.18.10.0170Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630971236608), received between Apr 17, 2019 and Apr 17, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 17, 2019Fracture; Fracture

  DURING THE PRIMARY KNEE SURGERY, THE TRIAL INSERT BROKE AS IT WAS BEING REMOVED WITH A KOCHER CLAMP. THE SURGEON HAD HIT IT DIRECTLY WITH A MALLET TO SEAT IT INTO THE TIBIAL TRAY. NO FRAGMENTS FELL INTO THE PATIENT'S SURGICAL WOUND AND THERE WAS NO DELAY IN THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8522858 ↗