DJO SURGICAL 241-01-110Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM FEMUR, NP, 10L · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888912166676), received between Oct 18, 2016 and Feb 12, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Appropriate Device Problem Term/Code Not Available1
- Fracture1
- Unstable1
Patient problems
- Insufficient Information1
- Joint Laxity1
- Loss of Range of Motion1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryFeb 12, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryFeb 9, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: DUE TO REMOVAL OF TEMPORARY SPACER TO TOTAL KNEE.
Patient problems: Insufficient Information
MAUDE report 13499703 ↗InjurySep 13, 2018Adverse Event Without Identified Device or Use Problem
THIRD REVISION SURGERY - DUE TO AN INFECTION. THE SURGEON TOOK ALL DJO COMPONENTS OUT AND PUT IN AN ANTIBIOTIC SPACER FOR INFECTION.
Patient problems: Unspecified Infection
MAUDE report 7874894 ↗InjuryOct 18, 2016Fracture
REVISION SURGERY - AFTER THE INDEX SURGERY (B)(6) 2016, THE PATIENT WAS NEVER ABLE TO ACHIEVE FULL EXTENSION, RANGE OF MOTION (ROM). THE SURGEON WENT IN TO PERFORM A SYNAVECTOMY AND POSSIBLY REVISE THE TIBIAL COMPONENT AND RESECT MORE OF THE PROXIMAL TIBIA. WHILE TRYING TO GET EXPOSURE, A PROXIMAL MEDIAL TIBIAL FRACTURE OCCURRED, THE SURGEON THEN EXTRACTED ALL OF THE COMPONENTS OTHER THAN THE PETELLA AND RE-IMPLANTED AN EXPRT REVISION KNEE.
Patient problems: Loss of Range of Motion
MAUDE report 6037852 ↗
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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