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BKS E-Vitalize 166-5207Recalls & reported problems

Ortho Development Corporation · Size 2 7mm Tibial Insert PS, Vitamin E · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822409006892), received between Jun 18, 2019 and Jun 18, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Misassembled During Installation” (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

Device problems

  • Misassembled During Installation1

Patient problems

  • Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 18, 2019Misassembled During Installation; Misassembled During Installation

    DURING TOTAL KNEE ARTHROPLASTY, THE SURGEON REPORTED THAT THE INSERT WAS NOT FULLY SEATED ONTO THE TIBIAL TRAY BY 1 TO 2 MM. THE SURGEON PERFORMED EXTENSION AND BENDING MOVEMENT, JUDGED THAT THERE WAS NO PROBLEM WITH STABILITY, AND THEN ENDED THE OPERATION.

    Patient problems: Pain

    MAUDE report 8708275 ↗

Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices →

Sources and updates

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