DJO SURGICAL 241-02-109Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM FEMUR, NP, 9R · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888912166768), received between Mar 6, 2018 and Sep 30, 2026 — classified as 6 injuries.
The most frequently reported specific device problem is “Unstable” (4 reports).
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.
Reports received per month
Most reported problems
Device problems
- Unstable4
- Adverse Event Without Identified Device or Use Problem2
- Contamination1
- Loose or Intermittent Connection1
Patient problems
- Joint Laxity4
- No Code Available2
- Failure of Implant1
- Unspecified Infection1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50941452 ↗InjuryDec 8, 2025Unstable; Unstable
InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 8, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMar 27, 2018Contamination
REVISION SURGERY - AFTER PROLONGED INFECTION AND SEVERAL WASHOUTS WITH INSERTS SWAPS, THE SURGEON REMOVED ALL PRIMARY IMPLANTS AND REPLACED THE FEMUR AND TIBIAL PROSTHESIS WITH EMPOWER KNEE IMPLANTS TO SERVE AS SPACERS UNTIL THE INFECTION SUBSIDED. WHEN THE INFECTION CLEARED THE SURGEON REMOVED THE SPACER IMPLANTS AND PERFORMED A SUCCESSFUL EXPERT KNEE REVISION.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 7374667 ↗InjuryMar 6, 2018Loose or Intermittent Connection; Unstable
REVISION SURGERY - DUE TO THE PATIENT BEING UNSTABLE, LOOSENING IMPLANTS.
Patient problems: Failure of Implant; No Code Available
MAUDE report 7318595 ↗
Other Guide, Surgical, Instrument devices
- NA 03.037.017Synthes GmbH · Guide, surgical, instrument346 reports
- EVOS 71174934Smith & Nephew, Inc. · Guide, surgical, instrument149 reports
- LCP 323.042Synthes GmbH · Guide, surgical, instrument129 reports
- DJO SURGICAL 342-10-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall51 reports
- DJO SURGICAL 341-10-707Encore Medical, L.P. · Guide, Surgical, Instrument81 reports
- NA 03.010.404Synthes GmbH · Guide, surgical, instrument73 reports
- DJO SURGICAL 341-14-708Encore Medical, L.P. · Guide, Surgical, Instrument1 recall22 reports
- DJO SURGICAL 341-10-711Encore Medical, L.P. · Guide, Surgical, Instrument1 recall16 reports
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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