Skip to content

DJO SURGICAL 370-19-504Recalls & reported problems

Encore Medical, L.P. · FOUNDATION® KNEE SYSTEM Constrained Revision PS Insert 19mm CM · Class 2 · Implant

Data updated Oct 18, 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 00888912116862), received between Jan 20, 2017 and Jan 20, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

  • Insufficient Device Problem Information1

Patient problems

  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryJan 20, 2017Insufficient Device Problem Information

    REVISION SURGERY - DUE TO A SMALL MINOR INFECTION; THE SURGEON REPLACED ALL OF THE COMPONENTS.

    Patient problems: Unspecified Infection

    MAUDE report 6266496 ↗

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