DJO SURGICAL 342-10-711Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 11R 10MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00888912167383), received between Dec 6, 2020 and Jul 27, 2026 — classified as 17 injuries.
The most frequently reported specific device problem is “Unstable” (2 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 Problem13
- Appropriate Device Problem Term/Code Not Available2
- Unstable2
- Patient Device Interaction Problem1
Patient problems
- Unspecified Infection12
- Joint Laxity3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Fall1
- Insufficient Information1
- Muscular Rigidity1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Patient Device Interaction Problem
Revision Surgery - Due to Loosening, instability after a fall.
Patient problems: Fall; Joint Laxity
MAUDE report 50010809 ↗InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem
InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem
PATIENT PRESENTED YESTERDAY TO THE ER WITH A FEVER, AND THEY WERE ABLE TO DRAW 150CC'S OF FLUID FROM THE KNEE. TODAY THEY UNDERWENT A WASHOUT WITH EXCHANGE OF THE POLYETHYLENE.
Patient problems: Unspecified Infection
MAUDE report 24408305 ↗InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem
InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INFECTION/POLY SWAP.
Patient problems: Unspecified Infection
MAUDE report 24000005 ↗InjuryOct 24, 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
REVISION SURGERY - DUE TO BLEEDING WASH OUT.
Patient problems: Insufficient Information
MAUDE report 19368063 ↗InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 20, 2023Unstable; Unstable
REVISION SURGERY - DUE INFECTION.
Patient problems: Joint Laxity; Unspecified Infection
MAUDE report 17357309 ↗InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 9, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO STIFFNESS IN KNEE. PATIENT NON COMPLIANT WITH POST OPERATIVE.
Patient problems: Muscular Rigidity
MAUDE report 15950089 ↗InjuryDec 16, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INFECTION. MODULAR COMPONENT WAS REMOVED AND REPLACED WITH NEW STERILE IMPLANTS.
Patient problems: Unspecified Infection
MAUDE report 13018341 ↗InjuryDec 6, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO POST OPERATION DRAINING. PATIENT WAS REVISED UNDER SUSPICION OF INFECTION. UPON GETTING INSIDE THE KNEE AGAIN, THE SURGEON DETERMINED THERE WAS NO INFECTION, BUT CHOSE TO PERFORM A POLY SWAP AND DEBRIDEMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 10955721 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page