DJO SURGICAL 341-12-709Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 9L 12MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO Surgical knee instrument is used during knee replacement surgery. Reports mostly describe infections and unstable knees leading to repeat surgery to exchange parts or clean the joint. There are 35 reports, including 34 injuries and no deaths. 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
- 33
- Deaths reported
- 0
- Injuries reported
- 33
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00888912166966), received between Aug 22, 2019 and May 29, 2026 — classified as 33 injuries.
The most frequently reported specific device problem is “Unstable” (5 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 Problem20
- Appropriate Device Problem Term/Code Not Available10
- Unstable5
- Loose or Intermittent Connection2
- No Apparent Adverse Event1
Patient problems
- Unspecified Infection20
- Joint Laxity5
- Insufficient Information4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Fall1
- Loss of Range of Motion1
- No Code Available1
- Pain1
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
InjuryMay 29, 2026Unstable
InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem
InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem
RESURFACE THE PATELLA AND SWAP POLY.
Patient problems: Insufficient Information
MAUDE report 24760297 ↗InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem
InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 24, 2025Unstable; Unstable
InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO POSSIBLE INFECTION.
Patient problems: Unspecified Infection
MAUDE report 23019243 ↗InjurySep 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 7, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMar 7, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 18, 2024No Apparent Adverse Event; No Apparent Adverse Event
REVISION SURGERY - DUE TO POLY NEEDS TO BE REPLACE PER SURGEON.
Patient problems: Insufficient Information
MAUDE report 19130897 ↗InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 27, 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
InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 20, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO STIFFNESS AND INFECTION.
Patient problems: Loss of Range of Motion; Unspecified Infection
MAUDE report 14463560 ↗InjuryApr 19, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAD GROSS LAXITY DUE TO SOFT TISSUE ISSUES. THICKER INSERT NEEDED.
Patient problems: Insufficient Information
MAUDE report 14142717 ↗InjuryNov 24, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO KNEE LAXITY.
Patient problems: Insufficient Information
MAUDE report 12872305 ↗InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT FELL AND RUPTURED HIS QUAD TENDON. SURGEON REMOVED THE POLY, DID AN EXTENSIVE WASH OUT, REPAIRED THE QUAD TENDON AND REPLACED THE POLY.
Patient problems: Fall; Rupture
MAUDE report 12525795 ↗
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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