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DJO SURGICAL 345-13-705Recalls & reported problems

Encore Medical, L.P. · EMPOWR CR KNEETM TIBIAL INSERT, RIGHT, SIZE 5, 13MM · 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 00190446216131), received between Apr 18, 2022 and Apr 18, 2022 — classified as 1 injury.

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 Available1
  • Loose or Intermittent Connection1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • InjuryApr 18, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY - DUE TO LOOSE KNEE. NOTHING WAS WRONG WITH THE IMPLANT, JUST REQUIRED READJUSTMENT.

    Patient problems: Insufficient Information

    MAUDE report 14137575 ↗

Other Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive devices

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Sources and updates

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