DJO SURGICAL 342-10-707Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 7R 10MM, VE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Encore Medical EMPOWER 3D knee insert is a semi-constrained artificial knee component used in total knee replacement. The 70 reports describe knee instability and looseness that sometimes led to revision surgery, along with infections at the surgical site and ongoing knee pain. There are no deaths, and 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
- 70
- Deaths reported
- 0
- Injuries reported
- 70
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 00888912167345), received between Jan 12, 2017 and Sep 22, 2026 — classified as 70 injuries.
The most frequently reported specific device problem is “Unstable” (11 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 Problem40
- Appropriate Device Problem Term/Code Not Available16
- Unstable11
- Loosening of Implant Not Related to Bone-Ingrowth2
- Device Operates Differently Than Expected1
- Insufficient Device Problem Information1
- Loose or Intermittent Connection1
- Material Integrity Problem1
Patient problems
- Unspecified Infection27
- Joint Laxity17
- Implant Pain5
- Medical device site infection5
- Insufficient Information4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Fall2
- Loss of Range of Motion2
Recent adverse event reports
The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.
InjurySep 22, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50862490 ↗InjuryJul 27, 2026Unstable
InjuryJul 15, 2026Unstable
REVISION SURGERY - DUE TO PATIENT FELT KNEE WAS OUT OF BALANCE.
Patient problems: Joint Laxity
MAUDE report 25831971 ↗InjuryMay 15, 2026Unstable
InjuryMay 6, 2026Insufficient Device Problem Information
REVISION SURGERY DUE TO POLY SWAP / UNKNOWN REVISION REASON.
Patient problems: Insufficient Information
MAUDE report 25107441 ↗InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem
InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem
InjuryJan 16, 2026Loosening of Implant Not Related to Bone-Ingrowth
InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT NEEDED AT I&D AND POLY SWAP.
Patient problems: Unspecified Infection
MAUDE report 23796723 ↗InjuryNov 10, 2025Unstable; Unstable
InjuryOct 31, 2025Unstable; Unstable
InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 23059674 ↗InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 22, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT IN PAIN. POLY EXCHANGE AND PATELLA RESURFACING.
Patient problems: Implant Pain
MAUDE report 20315636 ↗InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
Other Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive devices
- iTotal® PS TPS111111102Conformis, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive327 reports
- ATTUNE 1506-00-006Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive287 reports
- ATTUNE 1506-00-008Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive233 reports
- iTotal® Cruciate Retaining (CR) Knee Replacement System TCR121111102Conformis, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive150 reports
- ATTUNE 1506-70-007Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 recall2 deaths74 reports
- ATTUNE 1516-40-506Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive121 reports
- ATTUNE 1506-70-006Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 recall70 reports
- ATTUNE 1516-40-605Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive120 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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