DJO SURGICAL 342-12-704Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 4R 12MM, VE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00888912167413), received between Feb 3, 2017 and May 5, 2026 — classified as 16 injuries.
The most frequently reported specific device problem is “Unstable” (4 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 Problem8
- Unstable4
- Appropriate Device Problem Term/Code Not Available3
- Device Dislodged or Dislocated1
- Inadequacy of Device Shape and/or Size1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information6
- Joint Laxity5
- Unspecified Infection2
- Fall1
- No Known Impact Or Consequence To Patient1
- Wound Dehiscence1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem
InjuryApr 17, 2026Unstable
REVISION SURGERY- DUE TO PATIENT DEVELOPED INSTABILITY IN HER TOTAL KNEE.
Patient problems: Joint Laxity
MAUDE report 24918874 ↗InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 24274722 ↗InjuryJan 14, 2026Unstable
InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATELLA RESURFACING AND POLY SWAP, UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 24000044 ↗InjuryNov 26, 2025Unstable; Unstable
InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO NEEDED TO REMOVE HARDWARE, UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 21108228 ↗InjuryNov 7, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJun 29, 2024Adverse Event Without Identified Device or Use Problem; 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
InjuryMay 14, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE KNEE BECAME UNSTABLE.
Patient problems: Insufficient Information
MAUDE report 14403322 ↗InjuryJan 25, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT'S KNEE WAS HIGHLY UNSTABLE, SO FEMUR AND POLY WERE REMOVED AND A PS FEMUR AND PS POLY WERE IMPLANTED TO ACHIEVE GREATER STABILITY. POLY THICKNESS WAS INCREASED FROM 12MM TO 14MM.
Patient problems: Insufficient Information
MAUDE report 13343940 ↗InjuryAug 9, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - KNEE WAS DISLOCATED AND A LARGER INSERT WAS REQUIRED. REPLACED WITH 342-14-704 SIZE 4 14MM INSERT.
Patient problems: Insufficient Information
MAUDE report 12298485 ↗InjuryMar 21, 2017Insufficient Device Problem Information
REVISION SURGERY - DUE TO THE PATIENT SPLITTING HER INCISION AND THE SURGEON HAVING TO GO BACK IN AND DO A POLY SWAP.
Patient problems: Wound Dehiscence
MAUDE report 6421083 ↗InjuryFeb 3, 2017Inadequacy of Device Shape and/or Size
REVISION SURGERY - THE REVISION SURGERY WAS NEEDED FOR INCREASED STABILITY. THE ORIGINAL 12 MM POLY WAS EXCHANGED FOR A 14 MM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6300328 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page