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DJO SURGICAL 380-09-510Recalls & 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
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 00888912117081), received between Jan 12, 2021 and Mar 8, 2022 — 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

  • Appropriate Device Problem Term/Code Not Available2
  • Loose or Intermittent Connection1

Patient problems

  • Failure of Implant1
  • Insufficient Information1

Recent adverse event reports

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

  • InjuryMar 8, 2022Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY - THE POLY WAS WORN AND NEEDED REPLACEMENT.

    Patient problems: Insufficient Information

    MAUDE report 13694809 ↗
  • InjuryJan 12, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY - POLY LOOSENING.

    Patient problems: Failure of Implant

    MAUDE report 11155550 ↗

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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