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DJO SURGICAL 344-10-707Recalls & reported problems

Encore Medical, L.P. · EMPOWR CR KNEETM TIBIAL INSERT, LEFT, SIZE 7, 10MM · 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 00190446215134), received between Nov 20, 2019 and Nov 20, 2019 — classified as 1 injury.

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

Patient problems

  • Pain1
  • Swelling1
  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryNov 20, 2019Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY - PATIENT PRESENTED TO HOSPITAL WITH SIGNIFICANT KNEE, LEG PAIN AND SWELLING WHILE VISITING FAMILY IN CONNECTICUT FROM CALIFORNIA. AFTER INITIAL VISIT PHYSICIAN DIAGNOSED PATIENT WITH INFECTION SYMPTOMS AND CONTACTED DJO DISTRIBUTOR.

    Patient problems: Pain; Swelling; Unspecified Infection

    MAUDE report 9349570 ↗

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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