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DJO SURGICAL 370-13-510Recalls & reported problems

Encore Medical, L.P. · FOUNDATION® KNEE SYSTEM Constrained Revision PS Insert 13mm 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 00888912116718), received between Mar 25, 2021 and Mar 25, 2021 — 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

  • Failure of Implant1

Recent adverse event reports

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

  • InjuryMar 25, 2021Break

    REVISION SURGERY - REVISED POLY DUE TO FAILURE. THE POLY INSERT BROKE OUT OF LOCKING MECHANISM.

    Patient problems: Failure of Implant

    MAUDE report 11568857 ↗

Other Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer devices

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Sources and updates

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