INSTRUMENT I-K34960709Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327305043), received between Mar 29, 2019 and Mar 29, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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.

• MalfunctionMar 29, 2019Difficult to Insert; Difficult to Remove; Difficult to Insert; Difficult to Remove

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE INSERT TRIALS WERE DIFFICULT TO ENGAGE INTO THE BASEPLATE TRIAL, AND THEN WERE VERY DIFFICULT TO RELEASE. POST-OP, THE INSERT TRIALS WERE TESTED WITH SEVERAL OTHER BASEPLATE TRIALS AND EXHIBITED THE SAME BEHAVIOR. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE INSERT TRIALS ARE AVAILABLE FOR RETURN, AND THE REP REPORTED NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8466808 ↗