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DJO SURGICAL 345-10-708Recalls & reported problems

Encore Medical, L.P. · EMPOWR CR KNEETM TIBIAL INSERT, RIGHT, SIZE 8, 10MM · 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 00190446215868), received between Jun 16, 2020 and Jun 23, 2020 — classified as 2 injuries.

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

Patient problems

  • Unspecified Infection2

Recent adverse event reports

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

  • InjuryJun 23, 2020Appropriate Device Problem Term/Code Not Available

    SECOND REVISION SURGERY - DUE TO AN INFECTION.

    Patient problems: Unspecified Infection

    MAUDE report 10185054 ↗
  • InjuryJun 16, 2020Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY - THIS WAS AN INFECTION, NO ISSUES STRAIGHT FORWARD BEARING SWAP.

    Patient problems: Unspecified Infection

    MAUDE report 10158453 ↗

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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