DJO SURGICAL 241-02-107Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM FEMUR, NP, 7R · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00888912166744), received between Aug 8, 2017 and Aug 18, 2026 — classified as 17 injuries.
The most frequently reported specific device problem is “Unstable” (5 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 Problem12
- Unstable5
- Appropriate Device Problem Term/Code Not Available2
- Loose or Intermittent Connection1
- No Apparent Adverse Event1
Patient problems
- Joint Laxity7
- Insufficient Information4
- Fall3
- Unspecified Infection3
- Bone Fracture(s)2
- Limb Fracture1
- No Code Available1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
InjuryAug 18, 2026No Apparent Adverse Event
Revision surgery - Due to unknown reason.
Patient problems: Insufficient Information
MAUDE report 50311020 ↗InjuryJun 10, 2026Unstable
InjuryNov 26, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO FALL LOWER BODY/LAXITY.
Patient problems: Fall; Joint Laxity
MAUDE report 23653559 ↗InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT FELL 2 MONTHS POST OP AND FRACTURED THEIR FEMUR.
Patient problems: Bone Fracture(s); Fall
MAUDE report 22372550 ↗InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT FALL LOWER BODY/FRACTURE.
Patient problems: Bone Fracture(s); Fall; Limb Fracture
MAUDE report 21108231 ↗InjuryNov 11, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryOct 22, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - REVISION ON FEMORAL COMPONENT. CHANGED FROM 3D FEMUR TO REVISION FEMUR & VVC POLY.
Patient problems: Insufficient Information
MAUDE report 18611234 ↗InjuryJan 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 14, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT FELL AND HAD INSTABILITY AFTER THE FALL.
Patient problems: Joint Laxity
MAUDE report 18136938 ↗InjuryOct 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 8, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - REMOVED TEMPORARY SPACERS AND DID EXPERT REVISION KNEE.
Patient problems: Insufficient Information
MAUDE report 13479958 ↗InjuryMay 28, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - VALGUS KNEE. REVISION FOR ALIGNMENT.
Patient problems: Insufficient Information
MAUDE report 11901609 ↗InjuryAug 8, 2017Loose or Intermittent Connection
REVISION SURGERY - DUE TO THE COMPONENTS BEING LOOSE; THE SURGEON REMOVED AND REPLACED WITH EXPRT KNEE IMPLANTS.
Patient problems: No Code Available
MAUDE report 6774401 ↗
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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