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DJO SURGICAL 380-09-508Recalls & 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 00888912117074), received between Apr 6, 2016 and Apr 6, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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

  • Device Dislodged or Dislocated1

Patient problems

  • Joint Dislocation1

Recent adverse event reports

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

  • InjuryApr 6, 2016Device Dislodged or Dislocated

    REVISION SURGERY - DUE TO THE PATIENT'S KNEE DISLOCATING; THE SURGEON CHANGED OUT THE INSERT.

    Patient problems: Joint Dislocation

    MAUDE report 5552182 ↗

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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