DJO SURGICAL 342-14-704Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 4R 14MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888912167512), received between Feb 18, 2020 and Jul 2, 2026 — classified as 10 injuries.
The most frequently reported specific device problem is “Unintended Movement” (1 report).
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 Problem6
- Appropriate Device Problem Term/Code Not Available2
- Unintended Movement1
- Unstable1
Patient problems
- Unspecified Infection3
- Joint Laxity2
- Loss of Range of Motion2
- Fibrosis1
- Implant Pain1
- No Code Available1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryJul 2, 2026Unintended Movement
InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DR DID A RT. TKR ON THIS PATIENT ON THE PATIENT DEVELOPED STIFFNESS AND DECREASED RANGE OF MOTION OVER TIME. DR DID A REVISION AND REMOVED THE 4/14MM INSERT AND IMPLANTED A 4/10MM INSERT. THIS IMPROVED THE RANGE OF MOTION. FEMALE 74.
Patient problems: Loss of Range of Motion
MAUDE report 23735262 ↗InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO STIFFNESS.
Patient problems: Loss of Range of Motion
MAUDE report 18548487 ↗InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 25, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 13602640 ↗InjuryJul 8, 2021Appropriate Device Problem Term/Code Not Available
InjuryFeb 18, 2020Unstable
REVISION SURGERY: THE PATIENT HAD AN INSTABILITY IN FLEXION AND EXTENSION. SURGEON INCREASED THE POLY FROM 14 TO 19MM.
Patient problems: No Code Available
MAUDE report 9720006 ↗
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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