DJO SURGICAL 342-10-710Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 10R 10MM, VE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DJO Surgical EMPOWR 3D knee insert is used during knee surgery. The 41 reports mostly describe infections and joint instability, sometimes leading to revision surgery; there were 41 injuries and no deaths. No recalls name this device. Reports rose from 2 in the previous 12 months to 6 in the latest 12 months.
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
- 41
- Deaths reported
- 0
- Injuries reported
- 41
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00888912167376), received between May 30, 2018 and Aug 17, 2026 — classified as 41 injuries.
The most frequently reported specific device problem is “Unstable” (10 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem18
- Appropriate Device Problem Term/Code Not Available15
- Unstable10
- Break1
- Contamination1
Patient problems
- Unspecified Infection19
- Joint Laxity12
- Fall3
- Insufficient Information2
- Pain2
- Failure of Implant1
- Implant Pain1
- Loss of Range of Motion1
Recent adverse event reports
The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.
InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem
InjuryApr 6, 2026Unstable
InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem
InjuryJan 13, 2026Unstable
InjuryDec 8, 2025Unstable; Unstable
InjuryDec 4, 2025Unstable; Unstable
InjuryOct 19, 2025Unstable; Unstable
IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY AS THE PATIENT FELT SLIGHTLY UNSTABLE, RESULTING IN A CHANGE OF THE POLYETHYLENE INSERT AND PRIMARY RESURFACING OF THE PATELLA.
Patient problems: Joint Laxity
MAUDE report 23333902 ↗InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 31, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryOct 8, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 3, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PAIN AND STIFFNESS.
Patient problems: Implant Pain; Loss of Range of Motion
MAUDE report 19149679 ↗InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 1, 2022Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT WAS INFECTED.
Patient problems: Unspecified Infection
MAUDE report 15139110 ↗InjuryJun 21, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY- DUE TO INSTABILITY.
Patient problems: Insufficient Information
MAUDE report 14758101 ↗InjuryJun 14, 2022Appropriate Device Problem Term/Code Not Available
InjuryJun 9, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 14645926 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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