DJO SURGICAL 341-10-707Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 7L 10MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO EmPower knee surgical guide appears in 81 adverse event reports, with no deaths and 81 injuries. Reports mostly describe revision knee surgery, often due to loosening, instability or infection. 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
- 81
- Deaths reported
- 0
- Injuries reported
- 81
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 00888912166843), received between Feb 16, 2017 and Aug 18, 2026 — classified as 81 injuries.
The most frequently reported specific device problem is “Unstable” (21 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 Problem46
- Appropriate Device Problem Term/Code Not Available22
- Unstable21
- Loosening of Implant Not Related to Bone-Ingrowth1
- Material Split, Cut or Torn1
- Microbial Contamination of Device1
- No Apparent Adverse Event1
Patient problems
- Unspecified Infection28
- Joint Laxity20
- Fall6
- Insufficient Information5
- Pain5
- Failure of Implant4
- Loss of Range of Motion3
- Medical device site infection3
Recent adverse event reports
The 25 most recent of 81 reports, in the reporter's own words as published by the FDA.
InjuryAug 18, 2026No Apparent Adverse Event
Revision surgery - De to poly swap.
Patient problems: Insufficient Information
MAUDE report 50293552 ↗InjuryJul 27, 2026Unstable
InjuryMar 21, 2026Loosening of Implant Not Related to Bone-Ingrowth
InjuryMar 12, 2026Unstable
InjuryFeb 23, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - EXAMINATION OF SCRATCHES ON THE TREAD SURFACE OF THE PE INLAY AFTER APPROX. 8 MONTHS IN SITU. PRIMARY TKR SURGERY WAS PERFORMED ON (B)(6) 2025.
Patient problems: Insufficient Information
MAUDE report 24424155 ↗InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem
InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem
InjuryDec 16, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INFECTION, SURGEON DID A WASHOUT AND POLY SWAP.
Patient problems: Unspecified Infection
MAUDE report 23577360 ↗InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO, PATIENT FELL AND REOPENED WOUND, FLUSH AND POLY EXCHANGE WERE DONE.
Patient problems: Fall
MAUDE report 22378977 ↗InjuryJun 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO FALL LOWER BODY COMPONENT; HE POROUS COATED BASEPLATE FAILED WITH SUBSIDENCE.
Patient problems: Failure of Implant; Fall
MAUDE report 21931591 ↗InjuryApr 17, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryApr 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 10, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INFECTION AND INSTABILITY.
Patient problems: Joint Laxity; Unspecified Infection
MAUDE report 21407052 ↗InjuryJan 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 2, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryNov 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT COMPLAINED OF LEFT KNEE PAIN.
Patient problems: Implant Pain
MAUDE report 20660103 ↗InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 6, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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
- 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
- DJO SURGICAL 342-14-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall14 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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