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BKS E-Vitalize 166-5509Recalls & reported problems

Ortho Development Corporation · Size 5 9mm Tibial Insert PS, Vitamin E · Class 2 · Implant

Data updated Oct 13, 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 00822409007240), received between Apr 29, 2019 and Apr 29, 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. How this data works · Data updated Oct 13, 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.

  • InjuryApr 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    ON (B)(6) 2018, A PATIENT RECEIVED TOTAL KNEE ARTHROPLASTY. DURING FOLLOW UP, THE PATIENT COMPLAINED OF MINOR DISCOMFORT. UPON X-RAY EXAMINATION, THE SURGEON DETERMINED THAT THE INSERT HAD MIGRATED. ON (B)(6) 2019, THE KNEE WAS REVISED AND A NEW INSERT WAS PLACED IN THE PATIENT.

    Patient problems: Pain

    MAUDE report 8561217 ↗

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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