DJO SURGICAL 341-10-706Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 6L 10MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO surgical instrument is a3D knee alignment guide used during knee replacement surgery. The 51 reports describe knee instability, infection, pain, and the knee giving way, with several patients needing a second operation to revise or replace the implant. All reports list an injury and none list a death. 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
- 51
- Deaths reported
- 0
- Injuries reported
- 51
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00888912166836), received between Oct 28, 2016 and Jul 21, 2026 — classified as 51 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 Problem32
- Unstable11
- Appropriate Device Problem Term/Code Not Available7
- Insufficient Device Problem Information2
- No Apparent Adverse Event2
- Patient Device Interaction Problem2
- Device Contamination with Chemical or Other Material1
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- Unspecified Infection21
- Joint Laxity10
- Implant Pain5
- Insufficient Information4
- No Code Available4
- Fall2
- Medical device site infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.
InjuryJul 21, 2026No Apparent Adverse Event
REVISION SURGERY - POLY SWAP/UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 25898523 ↗InjuryJun 24, 2026Unstable
InjuryMay 29, 2026Unstable
InjuryMar 21, 2026Adverse Event Without Identified Device or Use Problem
InjuryDec 9, 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 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PAIN AND INFECTION.
Patient problems: Implant Pain; Unspecified Infection
MAUDE report 20274349 ↗InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO ORIGINAL SURGERY PERFORMED . PATIENT WAS HAVING DIFFICULTY GAINING FLEXION AND MANIPULATIONS HAD BEEN PERFORMED. SURGEON DECIDED TO TAKE PATIENT BACK TO OR, AND REMOVE THE POLY COMPONENT WHILE PERFORMING SCAR REMOVAL AND RELEASES TO FACILITATE FLEXION. PREOPERATIVELY PATIENT ONLY HAD APPROXIMATELY 60° FLEXION AND UPON COMPLETION OF SURGERY, PATIENT HAD APPROXIMATELY 110°. A NEW POLY INSERT OF SAME SIZE WAS RE-IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 20164367 ↗InjuryJun 29, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 13, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMay 10, 2024No Apparent Adverse Event; No Apparent Adverse Event
InjuryApr 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 14, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 24, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjurySep 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 18, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; 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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