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DJO SURGICAL 380-19-506Recalls & reported problems

Encore Medical, L.P. · FOUNDATION® KNEE SYSTEM Ultra-Congruent Insert 19mm CM · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888912117371), received between Feb 7, 2020 and Jul 9, 2020 — classified as 2 injuries.

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 18, 2026.

Most reported problems

Device problems

  • Appropriate Device Problem Term/Code Not Available2

Patient problems

  • No Code Available1
  • Unspecified Infection1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 9, 2020Appropriate Device Problem Term/Code Not Available

    SECOND REVISION SURGERY - DUE TO INFECTION.

    Patient problems: Unspecified Infection

    MAUDE report 10251921 ↗
  • InjuryFeb 7, 2020Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY - DUE TO POSSIBLE INFECTION.

    Patient problems: No Code Available

    MAUDE report 9681604 ↗

Other Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer devices

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Sources and updates

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