DJO SURGICAL 342-12-706Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 6R 12MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO Surgical EMPOWER 3D knee insert is used in knee replacement surgery. The 51 reports describe knees that became unstable or loose, with pain, reduced movement, falls and infection, and several patients needing revision surgery to swap out worn or damaged plastic parts. All 51 reports describe injuries, with no deaths. No recalls name 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
- 50
- Deaths reported
- 0
- Injuries reported
- 50
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00888912167437), received between Jan 19, 2017 and Aug 19, 2026 — classified as 50 injuries.
The most frequently reported specific device problem is “Unstable” (7 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 Problem25
- Appropriate Device Problem Term/Code Not Available18
- Unstable7
- Insufficient Device Problem Information2
- Device Dislodged or Dislocated1
- Loose or Intermittent Connection1
- Loosening of Implant Not Related to Bone-Ingrowth1
- No Apparent Adverse Event1
Patient problems
- Unspecified Infection18
- Joint Laxity9
- Fall6
- Implant Pain4
- Loss of Range of Motion4
- Insufficient Information3
- No Code Available2
- Bone Fracture(s)1
Recent adverse event reports
The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.
InjuryAug 19, 2026No Apparent Adverse Event
Revision surgery - Due to poly swap.
Patient problems: Insufficient Information
MAUDE report 50312421 ↗InjuryApr 3, 2026Unstable; Adverse Event Without Identified Device or Use Problem
InjuryFeb 24, 2026Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - DUE TO POLY BECAME WORN DOWN, LOOSE IN EXTENSION AND FLEXION.
Patient problems: Joint Laxity
MAUDE report 24437605 ↗InjuryJan 6, 2026Unstable
REVISION SURGERY - DUE TO STIFF KNEE SO SURGEON DID A POLY SWAP WITH PATELLA RESURFACING.
Patient problems: Loss of Range of Motion
MAUDE report 23986247 ↗InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
InjuryNov 17, 2025Unstable; Unstable
InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INFECTION, I&D AND POLY SWAP
Patient problems: Unspecified Infection
MAUDE report 23482485 ↗InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT HAVING KNEE PAIN, DOCTOR WENT IN AND REMOVED THE POLY TOOK OUT SCAR TISSUE AND PUT IN A NEW POLY.
Patient problems: Implant Pain
MAUDE report 22023646 ↗InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 2, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryAug 9, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO COMPLAINT OF BEING TIGHT.
Patient problems: Loss of Range of Motion
MAUDE report 19378346 ↗InjuryDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 18, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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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