DJO SURGICAL 241-02-106Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM FEMUR, NP, 6R · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00888912166737), received between Oct 18, 2018 and Feb 10, 2026 — classified as 16 injuries.
The most frequently reported specific device problem is “Unstable” (6 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
- Adverse Event Without Identified Device or Use Problem11
- Unstable6
- Appropriate Device Problem Term/Code Not Available2
- Positioning Problem1
Patient problems
- Joint Laxity8
- Insufficient Information3
- Implant Pain2
- No Code Available2
- Fall1
- Muscle/Tendon Damage1
- Unspecified Infection1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
InjuryFeb 10, 2026Unstable
InjuryFeb 10, 2026Unstable
InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT SUSTAINED A FEMUR FRACTURE AND EXPERIENCED SOME KNEE INSTABILITY. AS A RESULT, A REVISION SURGERY WAS REQUIRED.
Patient problems: Joint Laxity
MAUDE report 23069685 ↗InjuryMay 15, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMar 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO PATIENT PRIMARY FEMUR WAS LATERAL AND NOT EXTERNALLY ROTATED ENOUGH. TOOK OFF FEMUR AND INSERT, PUT ON BETTER PLACED.
Patient problems: Insufficient Information
MAUDE report 21221546 ↗InjuryAug 13, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT COMPLAINT OF PAIN/INSTABILITY. SURGEON TESTED FOR LAXITY OF JOINT. TIBIA COMPONENT FOUND TO BE LOOSE.
Patient problems: Implant Pain; Joint Laxity
MAUDE report 19978346 ↗InjuryJul 13, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO FALL LOWER BODY COMPONENT/RUPTURED PATELLA TENDON
Patient problems: Muscle/Tendon Damage
MAUDE report 18874132 ↗InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - TWO STAGE REVISION.
Patient problems: Insufficient Information
MAUDE report 16424129 ↗InjuryDec 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT FELL CAUSING HER FEMUR IMPLANT TO BECOME LOOSE.
Patient problems: Fall; Joint Laxity
MAUDE report 15898520 ↗InjuryMay 25, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO FEMUR BONE LOSS. REMOVED FEMUR AND POLY.
Patient problems: Insufficient Information
MAUDE report 14498304 ↗InjuryJun 2, 2020Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT EMAILED DJO SURGICAL STATING THAT THEY HAD A REVISION SURGERY DUE TO SEVERAL COMPLICATIONS FROM INSTALLING THE KNEE AT 4 DEGREE VARUS ANGLE DEVELOPED. THE KNEE WAS REVISED WITH A DIFFERENT TOTAL KNEE REPLACEMENT. THE DJO KNEE WAS RETURNED TO THE PATIENT POST REVISION SURGERY AND IS WILLING TO SEND BACK IF WANTED.
Patient problems: No Code Available
MAUDE report 10108751 ↗InjuryMar 27, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT ACQUIRING A POST OPERATIVE INFECTION. THE SURGEON RESEATED HER KNEE AND PUT IN AN ARTICULATING CEMENT SPACER.
Patient problems: Unspecified Infection
MAUDE report 8458090 ↗InjuryOct 18, 2018Unstable; Positioning Problem
REVISION SURGERY - DUE TO THE SURGEON CORRECTING THE POSITION OF THE FEMUR AND REPLACING THE POLY AS WELL. THE SURGEON REMOVED THE FEMUR BECAUSE HE FELT IT WAS IN-VALGUS AND CAUSING INSTABILITY.
Patient problems: No Code Available
MAUDE report 7981147 ↗
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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