BKS E-Vitalize 166-5307Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00822409007004), received between Jun 26, 2018 and Jun 24, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Positioning Problem” (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 16, 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.

• MalfunctionJun 24, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING TOTAL KNEE ARTHROPLASTY, THE INSERT HAD SOME "FLOAT" AFTER IT WAS INSERTED. THE SURGEON REMOVED IT AND APPLIED IT AGAIN MULTIPLE TIMES BUT WITH THE SAME RESULT. A SECOND INSERT WAS OBTAINED AND APPLIED BUT "FLOAT" WAS STILL PRESENT. IT WAS REMOVED AND REINSERTED 2 MORE TIMES. UPON THE 3RD INSERTION, THE SURGEON SAID IT FIT AND COMPLETED THE NORMAL STRETCHING AND FLEXING EXERCISES TO CONFIRM STABILITY BEFORE CLOSING. SUBSEQUENTLY, THE LOCAL REPRESENTATIVE EXAMINED THE FIRST INSERT AND NOTED DEFORMATION IN THE POLY. THIS REPORT IS FILED BECAUSE THE LOCAL REPRESENTATIVE REPORTED THAT THE SECOND INSERT WAS NOT LOCKED.

  Patient problems: Arthritis

  MAUDE report 10189917 ↗
• InjuryJun 26, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE INDEX SURGERY OCCURRED ON (B)(6) 2018. THE REPORT INDICATES THAT THE TIBIAL INSERT WAS OUT OF POSITION SO A REVISION WAS PERFORMED ON (B)(6) 2018 TO REPLACE THE TIBIAL INSERT. THE SURGEON INDICATED THAT DURING THE INITIAL SURGERY, HE HAD DIFFICULTY PROPERLY FITTING THE INSERT INTO THE CONSTRUCT USING HIS MIS TECHNIQUE. THE SURGEON ALSO REPORTED THAT THERE WAS DEFORMATION ON THE TIBIAL INSERT. THE INSERT WAS DISCARDED AND NOT RETURNED.

  Patient problems: No Code Available

  MAUDE report 7638091 ↗