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DJO SURGICAL 370-11-510Recalls & reported problems

Encore Medical, L.P. · FOUNDATION® KNEE SYSTEM Constrained Revision PS Insert 11mm 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 00888912116657), received between Aug 2, 2019 and Aug 4, 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

  • Adverse Event Without Identified Device or Use Problem1
  • Appropriate Device Problem Term/Code Not Available1

Patient problems

  • Injury1
  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryAug 4, 2020Adverse Event Without Identified Device or Use Problem

    REVISION SURGERY - PATIENT PRESENTED REPEATED INFECTION. SURGEON DECIDED TO REMOVE ALL IMPLANTS TO WASH OUT THE INFECTED KNEE AND IMPLANT AN ANTIBIOTIC SPACER.

    Patient problems: Unspecified Infection

    MAUDE report 10362048 ↗
  • InjuryAug 2, 2019Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY - PATIENT HAD AN INJURY. CHANGED OUT INSERT WHILE IRRIGATION & DRAINAGE WAS PERFORMED.

    Patient problems: Injury

    MAUDE report 8855887 ↗

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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