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BKS E-Vitalize 166-7407Recalls & reported problems

Ortho Development Corporation · Size 4 7mm Tibial Insert UC · 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 00822409032549), received between Jul 13, 2017 and Jul 13, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Off-Label Use” (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

  • Off-Label Use1

Patient problems

  • Limited Mobility Of The Implanted Joint1

Recent adverse event reports

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

  • MalfunctionJul 13, 2017Off-Label Use; Off-Label Use

    A TOTAL KNEE REPLACEMENT SURGERY WAS PERFORMED IN WHICH AN UC (ULTRA CONGRUENT) TIBIAL INSERT WAS IMPLANTED WITH A PS (POSTERIOR STABILIZED) FEMORAL COMPONENT WHICH IS NOT INDICATED AS A COMPATIBLE COMBINATION.

    Patient problems: Limited Mobility Of The Implanted Joint

    MAUDE report 6713052 ↗

Other Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive devices

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Sources and updates

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