DJO SURGICAL 342-14-707Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 7R 14MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00888912167543), received between Mar 31, 2017 and Feb 24, 2026 — classified as 19 injuries.
The most frequently reported specific device problem is “Unstable” (8 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 Problem8
- Unstable8
- Appropriate Device Problem Term/Code Not Available5
- Device Dislodged or Dislocated1
Patient problems
- Insufficient Information4
- Joint Laxity4
- Unspecified Infection4
- No Code Available2
- Failure of Implant1
- Fall1
- Joint Dislocation1
- Pain1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
InjuryFeb 24, 2026Device Dislodged or Dislocated
InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO POLY EXCHANGE/DEVICE UNACCEPTABLE.
Patient problems: Insufficient Information
MAUDE report 21880684 ↗InjuryDec 12, 2024Unstable; Unstable
InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 22, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DR. COMPLETED A FEMUR ONLY REVISION. REMOVED POLY & FEMUR AND REPLACED WITH NEW EMPOWR REVISION FEMUR & VVC.
Patient problems: Insufficient Information
MAUDE report 18243793 ↗InjuryOct 27, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryDec 30, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INSTABILITY.
Patient problems: Insufficient Information
MAUDE report 13123014 ↗InjuryOct 22, 2021Appropriate Device Problem Term/Code Not Available
InjuryApr 21, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO QUAD TENDON PARTIAL RUPTURE. REPLACED THE INSERT.
Patient problems: Rupture
MAUDE report 11704184 ↗InjuryFeb 16, 2021Unstable
REVISION SURGERY - PATIENT'S KNEE WAS UNSTABLE WITH THE 14MM POLY ORIGINALLY IMPLANTED. SURGEON REVISED POLY WITH A 19MM POLY AND STABILITY WAS ACHIEVED.
Patient problems: Insufficient Information
MAUDE report 11332452 ↗InjuryNov 18, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT FALLING AND OPENING THE WOUND DOCTOR DID A POLY SWAP.
Patient problems: Fall
MAUDE report 9338806 ↗InjuryNov 8, 2019Unstable
InjurySep 23, 2019Unstable
REVISION SURGERY - THE PATIENT HAD INSTABILITY AND PAIN.
Patient problems: Pain
MAUDE report 9105701 ↗InjuryJul 31, 2019Unstable; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - SURGEON AND PATIENT DECIDED TO INCREASE STABILITY OF PRIMARY KNEE BY ADDING THICKNESS TO THE POLY INSERT.
Patient problems: Failure of Implant
MAUDE report 8846932 ↗InjuryJan 22, 2018Unstable
REVISION SURGERY - DUE TO THE PATIENT HAVING INSTABILITY POST-OPERATIVELY. THE SURGEON INCREASED THE POLY THICKNESS FROM 14 MM TO 19 MM.
Patient problems: No Code Available
MAUDE report 7209746 ↗InjuryMar 31, 2017Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION; THE SURGEON SWITCHED OUT AND REPLACED THE ORIGINAL INSERT.
Patient problems: Unspecified Infection
MAUDE report 6450216 ↗
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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