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DJO SURGICAL 380-09-512Recalls & reported problems

Encore Medical, L.P. · FOUNDATION® KNEE SYSTEM Ultra-Congruent Insert 9mm 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 00888912117098), received between Sep 4, 2019 and Sep 4, 2019 — classified as 1 injury.

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 Available1

Patient problems

  • 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 4, 2019Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY INFECTED KNEE WASH OUT AND POLY SWAP.

    Patient problems: No Code Available

    MAUDE report 8962025 ↗

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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