DJO SURGICAL 241-02-110Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM FEMUR, NP, 10R · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888912166775), received between Jun 16, 2017 and Apr 16, 2026 — classified as 7 injuries.
The most frequently reported specific device problem is “Unstable” (2 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
- Unstable2
- Collapse1
- Loose or Intermittent Connection1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Joint Laxity2
- No Known Impact Or Consequence To Patient2
- Failure of Implant1
- Implant Pain1
- Insufficient Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryApr 16, 2026Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY DUE TO COMPONENT LOOSENING. FEMUR WAS LOOSER, BUT TIBIA WAS LOOSE AS WELL.
Patient problems: Joint Laxity
MAUDE report 24901673 ↗InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT WAS HAVING PAIN
Patient problems: Implant Pain
MAUDE report 20434669 ↗InjuryDec 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DR. REMOVED 3D FEMUR & POLY & REPLACED WITH REVISION FEMUR & VVC POLY.
Patient problems: Insufficient Information
MAUDE report 18422509 ↗InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 3, 2020Unstable
REVISION SURGERY - DUE TO INSTABILITY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9547412 ↗InjuryJan 16, 2019Unstable
REVISION SURGERY - DUE TO THE PATIENT HAVING INSTABILITY.
Patient problems: Failure of Implant
MAUDE report 8254544 ↗InjuryJun 16, 2017Collapse; Loose or Intermittent Connection
REVISION SURGERY - DUE TO ASEPTIC LOOSENING, TIBIAL COMPONENT. RIGHT TIBIAL COLLAPSE; CAUSE POOR BONE QUALITY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6648511 ↗
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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