DJO SURGICAL 801-05-072Recalls & reported problems
Encore Medical, L.P. · DJO EMPOWR KNEETM TIBIAL EM DISTAL BODY ANKLE CLAMP · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00190446278078), received between Aug 7, 2019 and Sep 13, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Defective Component” (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
- Defective Component1
- Loose or Intermittent Connection1
Patient problems
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 13, 2021Defective Component
INSTRUMENT FAILURE - DUE TO ISSUES WITH THE SPRINGS ON THE ANKLE CLAMP.
Patient problems: Insufficient Information
MAUDE report 12465012 ↗MalfunctionAug 7, 2019Loose or Intermittent Connection
PRODUCT PROBLEM: DURING A RIGHT TOTAL KNEE ARTHROPLASTY (TKA), WHILE USING THE ANKLE CLAMP FROM THE COMPLETE TIBIA PREP TRAY, THERE WAS AN ISSUE WITH THE KNOB ON THAT ANKLE CLAMP LOOSENING DUE TO VIBRATIONS WHILE SAWING. THE KNOB IS USED TO ADJUST FOR VARUS OR VALGUS, AND WAS LOOSENED ALL THE WAY MEDIAL, WHICH COULD HAVE RESULTED IN AN EXTREME VALGUS CUT. IT DID NOT SEEM TO AFFECT THE TIBIAL CUT BUT IF IT CAME LOOSE EARLIER IN THE CUT IT MAY HAVE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8871675 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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