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DJO SURGICAL 370-17-502Recalls & reported problems

Encore Medical, L.P. · FOUNDATION® KNEE SYSTEM Constrained Revision PS Insert 17mm 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 00888912116794), received between Sep 11, 2017 and Sep 11, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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

  • Break1

Patient problems

  • Fall1
  • No Code Available1

Recent adverse event reports

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

  • InjurySep 11, 2017Break

    REVISION SURGERY - DUE TO THE PATIENT FALLING AND BREAKING THE POLY POST AND SCREW OFF. THE SURGEON DETERMINED THAT HE NEEDED TO REPLACE THE POLY. THE DJO REP SAID THE PRIMARY SURGERY WAS IN 2006 AND THEN A REVISION IN 2009.

    Patient problems: Fall; No Code Available

    MAUDE report 6854971 ↗

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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