DJO SURGICAL 342-14-706Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 6R 14MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a surgical instrument guide used with the DJO Empowr 3D Knee system. There are 25 adverse event reports naming its identifier, with 25 injuries and no deaths; reports mostly describe patients needing revision knee surgery because of joint instability or infection. 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
- 25
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00888912167536), received between Nov 22, 2017 and Feb 10, 2026 — classified as 25 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 Problem15
- Unstable8
- Appropriate Device Problem Term/Code Not Available4
- Device Dislodged or Dislocated1
- Loose or Intermittent Connection1
Patient problems
- Joint Laxity11
- Unspecified Infection8
- Implant Pain2
- No Code Available2
- Failure of Implant1
- Fall1
- Insufficient Information1
- Medical device site infection1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
InjuryFeb 10, 2026Unstable
InjuryOct 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO DOCTOR DECIDED TO DO A PATELLA RESURFACING AND POLY EXCHANGE.
Patient problems: Insufficient Information
MAUDE report 22216162 ↗InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; 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
InjuryApr 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 15, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJan 8, 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 18472311 ↗InjuryNov 13, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO AN INFECTION.
Patient problems: Medical device site infection
MAUDE report 15801279 ↗InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT HAD PRIMARY SURGERY DONE, HE RECEIVED IRRIGATION AND DRAINAGE POLY SWAP, AND CORRECT SIDE 6X14MM RIGHT 3D INSERT WAS IMPLANTED.
Patient problems: Joint Laxity
MAUDE report 15634116 ↗InjuryJun 10, 2022Unstable
InjuryApr 13, 2022Unstable
InjuryMar 28, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATIENT HAD AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 13932546 ↗InjuryFeb 17, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATIENT'S LIGAMENTS GAVE OUT RESULTING IN THE KNEE TO BE LOOSE.
Patient problems: Joint Laxity
MAUDE report 13548612 ↗InjuryDec 5, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INFECTED KNEE, DID WASHOUT.
Patient problems: Unspecified Infection
MAUDE report 10951148 ↗InjuryOct 7, 2020Device Dislodged or Dislocated
InjuryMar 5, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT FELL AND OPENED INCISION / POSSIBLE INFECTION. COMPLETED A WASHOUT AND POLY SWAP. THE SURGEON NOTICED THE POLY WAS A LITTLE LOOSE SO HE WENT UP A SIZE FOR THE POLY.
Patient problems: Fall
MAUDE report 9794005 ↗InjuryDec 19, 2019Unstable
REVISION SURGERY - SUSPECTED INFECTION AND INSTABILITY.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 9495250 ↗InjuryMar 12, 2019Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT ACQUIRING A POST OPERATIVE INFECTION. THE SURGEON PERFORMED A WASHOUT AND CHANGED THE POLY.
Patient problems: Unspecified Infection
MAUDE report 8412522 ↗InjuryNov 22, 2017Unstable
REVISION SURGERY - DUE TO THE PATIENT HAVING INSTABILITY.
Patient problems: No Code Available
MAUDE report 7053186 ↗
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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