DJO SURGICAL 241-01-109Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM FEMUR, NP, 9L · 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 00888912166669), received between Jul 15, 2021 and Apr 22, 2026 — classified as 4 injuries.
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 Problem3
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Fall1
- Insufficient Information1
- Loss of Range of Motion1
- Muscular Rigidity1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT WAS NOT SATISFIED WITH THE OUTCOME.
Patient problems: Insufficient Information
MAUDE report 24961033 ↗InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT'S KNEE WAS STIFF.
Patient problems: Loss of Range of Motion
MAUDE report 23318675 ↗InjuryDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - KNEE WAS STIFF, NEEDED REVISION FEMUR WITH STEM.
Patient problems: Muscular Rigidity
MAUDE report 15917507 ↗InjuryJul 15, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY . HE HAS SUDDEN ONSET DEMENTIA AND HAS FALLEN A VARIETY OF TIMES AT HIS REHAB FACILITY. HE ALSO HOLDS ON TO HIS LEG IN FLEXION AND DOES NOT DO ANY EXERCISES TO IMPROVE HIS RANGE OF MOTION. HE UNDERWENT A REVISION KNEE DUE TO HIS KNEE BEING "LOCKED" IN 90 DEGREES OF FLEXION.
Patient problems: Fall
MAUDE report 12177041 ↗
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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