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BKS E-Vitalize 166-5518Recalls & reported problems

Ortho Development Corporation · Size 5 18mm 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
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822409007318), received between May 7, 2019 and May 7, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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

  • Detachment of Device or Device Component1

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.

  • InjuryMay 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    ON (B)(6) 2019, THE PATIENT RECEIVED TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT REPORTED PAIN. AN X-RAY CONFIRMED THAT THE TIBIAL INSERT HAD MIGRATED FROM ITS ORIGINAL POSITION. ON (B)(6) 2019, THE SURGEON REVISED THE KNEE AND REPLACED THE 18MM INSERT WITH A 20MM INSERT.

    Patient problems: Pain

    MAUDE report 8588975 ↗

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

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

Sources and updates

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