Skip to content

DJO SURGICAL 380-19-504Recalls & 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 00888912117364), received between Nov 1, 2017 and Nov 18, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Loose or Intermittent Connection1
  • Naturally Worn1

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.

  • InjuryNov 18, 2020Adverse Event Without Identified Device or Use Problem

    REVISION SURGERY - DUE TO AN INFECTION.

    Patient problems: Unspecified Infection

    MAUDE report 10862177 ↗
  • InjuryNov 1, 2017Loose or Intermittent Connection; Naturally Worn

    REVISION SURGERY - DUE TO THE POLY WEARING OVER TIME AND SCREW BECOMING LOOSE.

    Patient problems: No Code Available

    MAUDE report 6994389 ↗

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

How reports and recalls are matched · Editorial policy · Report an error on this page