DJO SURGICAL 342-10-706Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 6R 10MM, VE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Encore Medical EMPOWER 3D knee insert is a component used in total knee replacement. The 73 reports mostly describe a knee that feels loose or unstable, infections, and pain, and many mention repeat surgery to replace or revise the implant; no deaths were reported. One open recall, started in December 2024, says some knee insert packages may contain a hip (acetabular) system instead, which can delay surgery while a new product is obtained.
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
- 69
- Deaths reported
- 0
- Injuries reported
- 69
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 00888912167338), received between Dec 22, 2016 and Aug 4, 2026 — classified as 69 injuries.
The most frequently reported specific device problem is “Unstable” (16 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Dec 10, 2024Class IIOpen, Classified
Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.
Z-0761-2025 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem44
- Unstable16
- Appropriate Device Problem Term/Code Not Available14
- No Apparent Adverse Event2
- Device Dislodged or Dislocated1
- Device Operates Differently Than Expected1
- Loose or Intermittent Connection1
- Microbial Contamination of Device1
Patient problems
- Joint Laxity27
- Unspecified Infection25
- Fall5
- Pain4
- Implant Pain3
- Insufficient Information3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Failure of Implant1
Recent adverse event reports
The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.
InjuryAug 4, 2026No Apparent Adverse Event
Revision surgery - Due to unknown reason.
Patient problems: Insufficient Information
MAUDE report 50136082 ↗InjuryJul 20, 2026Adverse Event Without Identified Device or Use Problem
InjuryJul 2, 2026Unstable
InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem
InjuryApr 23, 2026Unstable
InjuryApr 7, 2026Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMar 2, 2026Unstable
InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 10, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INSTABILITY AND PAIN.
Patient problems: Implant Pain; Joint Laxity
MAUDE report 23022874 ↗InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT FELL AND REOPENED HER INITIAL WOUND, CLEANED AND FLUSHED THE WOUND, EXCHANGED THE POLY FOR EXTRA INFECTION PREVENTION.
Patient problems: Fall; Unspecified Infection
MAUDE report 22332715 ↗InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY: DUE TO PATIENT FELL AND OPENED WOUND. POLY EXCHANGE.
Patient problems: Fall
MAUDE report 22254271 ↗InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 15, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryDec 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 12, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryOct 21, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryOct 17, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 14, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjurySep 3, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 23, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; 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 · each recall links to the FDA recall notice
- 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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