DJO SURGICAL 341-10-704Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 4L 10MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO Surgical EMPOWR 3D knee implant is used in knee replacement surgery. The 33 reports mostly describe the knee becoming unstable or the implant loosening, sometimes requiring revision surgery, along with pain and infection. No deaths were reported; all 33 reports involved injuries. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 33
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00888912166812), received between Jan 18, 2017 and Jun 14, 2026 — classified as 33 injuries.
The most frequently reported specific device problem is “Unstable” (14 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 Problem14
- Unstable14
- Appropriate Device Problem Term/Code Not Available8
- Loose or Intermittent Connection2
- Loosening of Implant Not Related to Bone-Ingrowth1
- Material Rupture1
- Patient Device Interaction Problem1
Patient problems
- Joint Laxity10
- Insufficient Information5
- Failure of Implant3
- Fall3
- Unspecified Infection3
- No Code Available2
- Pain2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
InjuryJun 14, 2026Unstable
InjuryMay 27, 2026Unstable
InjuryMay 17, 2026Patient Device Interaction Problem
InjuryApr 14, 2026Unstable; Adverse Event Without Identified Device or Use Problem
InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT FELL TWICE AFTER INITIAL SURGERY AND OPENED WOUND.
Patient problems: Fall
MAUDE report 21940270 ↗InjuryApr 28, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryDec 12, 2024Unstable; Unstable
InjuryOct 14, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJun 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO FEMORAL COMPONENT WAS NOT FIXATING TO THE FEMUR.
Patient problems: Insufficient Information
MAUDE report 19494866 ↗InjuryMay 21, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PAIN AND INSTABILITY.
Patient problems: Implant Pain; Joint Laxity
MAUDE report 19368054 ↗InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT HAD A FALL AND FRACTURED THEIR PATELLA. THE SURGEON PUT IN A NEW INSERT DURING THE PATELLA SURGERY.
Patient problems: Bone Fracture(s); Fall
MAUDE report 18237188 ↗InjurySep 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO FALL LOWER BODY COMPONENT.
Patient problems: Insufficient Information
MAUDE report 17786466 ↗InjuryAug 29, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO FALL, LOWER BODY - LOOSENING.
Patient problems: Joint Laxity
MAUDE report 16281014 ↗InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THERE WAS AN ACUTE INFECTION ON THE OPERATIVE SITE, THAT WAS WASHED OUT AND REPLACED WITH A NEW IMPLANT OF THE SAME DIMENSION.
Patient problems: Medical device site infection
MAUDE report 15949974 ↗InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT HAD REDUCED RANGE OF MOTION, DUE TO START TISSUE.
Patient problems: Loss of Range of Motion
MAUDE report 15792861 ↗InjuryMay 10, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INSTABILITY.
Patient problems: Insufficient Information
MAUDE report 14346375 ↗InjuryApr 29, 2022Unstable
REVISION SURGERY THE PATIENT FELL AND HAS HAD SIGNIFICANT INSTABILITY IN FLEXION AND EXTENSION.
Patient problems: Fall
MAUDE report 14250922 ↗InjuryMar 28, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAD INSTABILITY.
Patient problems: Insufficient Information
MAUDE report 13932401 ↗InjuryJan 19, 2022Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY : ITEM WAS LOOSE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13290325 ↗InjuryNov 9, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATIENT HAD INSTABILITY.
Patient problems: Insufficient Information
MAUDE report 12780820 ↗InjurySep 14, 2021Unstable; Appropriate Device Problem Term/Code Not Available
InjurySep 8, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAD INFECTION. REMOVED AND REPLACED THE INSERT.
Patient problems: Unspecified Infection
MAUDE report 12439742 ↗InjuryJun 14, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INFECTION, IRRIGATION & DRAINAGE WAS DONE AND INSERT EXCHANGED.
Patient problems: Unspecified Infection
MAUDE report 11996820 ↗
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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