DJO SURGICAL 241-01-107Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM FEMUR, NP, 7L · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888912166645), received between Mar 3, 2020 and Apr 14, 2026 — classified as 8 injuries.
The most frequently reported specific device problem is “Unstable” (3 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 Problem3
- Unstable3
- Appropriate Device Problem Term/Code Not Available2
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Joint Laxity4
- Insufficient Information3
- No Code Available1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryApr 14, 2026Unstable
SURGEON REVISED FEMUR BY TAKING THE CURRENT ONE OFF AND IMPLANTING THE ENOVIS REVISION FEMUR DUE TO INSTABILITY.
Patient problems: Joint Laxity
MAUDE report 24879890 ↗InjuryDec 17, 2025Unstable; Unstable
InjuryApr 22, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryNov 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 20701571 ↗InjuryFeb 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 21, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - NO TIBIA CEMENTED PREVIOUSLY, SO SURGEON REVISED TO ADD TIBIA COMPONENTS AND HAD TO REPLACE EXISTING COMPONENTS.
Patient problems: Insufficient Information
MAUDE report 13841007 ↗InjuryDec 2, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO SINGLE COMPONENT REVISION OF FEMUR ONLY.
Patient problems: Insufficient Information
MAUDE report 10932539 ↗InjuryMar 3, 2020Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - THE FEMORAL BEGAN TO LOOSENING.
Patient problems: No Code Available
MAUDE report 9779826 ↗
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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