DJO SURGICAL 342-12-709Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 9R 12MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO Surgical Empowr knee insert is a plastic spacer used in knee replacement. The 36 reports describe infections and knees feeling loose or unstable, often leading to another operation to replace the spacer. There are no deaths and 36 injuries mentioned, and 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
- 35
- Deaths reported
- 0
- Injuries reported
- 35
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00888912167468), received between Dec 3, 2016 and Aug 19, 2026 — classified as 35 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 Problem23
- Unstable11
- Appropriate Device Problem Term/Code Not Available6
- No Apparent Adverse Event1
- Patient Device Interaction Problem1
Patient problems
- Unspecified Infection13
- Joint Laxity10
- Insufficient Information5
- Fall2
- Implant Pain2
- Medical device site infection2
- No Code Available2
- Failure of Implant1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
InjuryAug 19, 2026No Apparent Adverse Event
Revision surgery - Due to unknown revision reason / Poly Swap.
Patient problems: Insufficient Information
MAUDE report 50312445 ↗InjuryJul 14, 2026Adverse Event Without Identified Device or Use Problem
InjuryJun 29, 2026Unstable
REVISION SURGERY - DUE TO THE PATIENT HAS DEVELOPED INSTABILITY.
Patient problems: Joint Laxity
MAUDE report 25660428 ↗InjuryJun 3, 2026Patient Device Interaction Problem
REVISION SURGERY - DUE TO TIGHT/LOSS OF ROM.
Patient problems: Loss of Range of Motion
MAUDE report 25369529 ↗InjuryDec 16, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY TO REPLACE POLY.
Patient problems: Insufficient Information
MAUDE report 23399417 ↗InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 30, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; 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
REVISION SURGERY - DUE TO PATIENT FELL LEADING TO OPEN JOINT CAPSULE.
Patient problems: Insufficient Information
MAUDE report 19581349 ↗InjuryApr 1, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMar 28, 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 19001210 ↗InjuryFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO DR. COMPLETE FULL REVISION OF A PREVIOUSLY IMPLANTED 3D KNEE (PRESSFIT).
Patient problems: Insufficient Information
MAUDE report 18794354 ↗InjuryNov 20, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; 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
InjuryApr 21, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 30, 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 16077580 ↗InjuryOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - INFECTION REQUIRED A POLY SWAP.
Patient problems: Medical device site infection
MAUDE report 15670246 ↗InjuryAug 5, 2022Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATEINT FELL POST OPERATION AND CAUSED THE WOUND TO OPEN WHICH RESULTED IN AN INFECTION.
Patient problems: Fall; Unspecified Infection
MAUDE report 15176679 ↗InjuryMar 21, 2022Unstable
REVISION SURGERY: DUE TO MIDFLECTION INSTABILITY.
Patient problems: Joint Laxity
MAUDE report 13841008 ↗InjuryJan 6, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 13173660 ↗
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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