DJO SURGICAL 341-12-710Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 10L 12MM, VE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DJO Surgical EMPOWR knee guide is a surgical instrument used in knee procedures. Reports mostly describe follow-up surgeries to treat infections, with some mentioning loosening, pain and unstable joints. There are 24 reports naming its identifier, with 24 mentioning injuries and no deaths, 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
- 23
- Deaths reported
- 0
- Injuries reported
- 23
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00888912166973), received between Mar 22, 2018 and Feb 24, 2026 — classified as 23 injuries.
The most frequently reported specific device problem is “Unstable” (3 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 Problem17
- Appropriate Device Problem Term/Code Not Available4
- Unstable3
- Device Dislodged or Dislocated1
- Patient-Device Incompatibility1
Patient problems
- Unspecified Infection12
- Joint Laxity4
- Fall2
- Implant Pain2
- Medical device site infection2
- Bacterial Infection1
- Failure of Implant1
- Foreign Body In Patient1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem
InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 5, 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 PATIENT WAS EXPERIENCING PAIN, SURGEON SUSPECTED INFECTION.
Patient problems: Implant Pain; Unspecified Infection
MAUDE report 21108229 ↗InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INFECTION AND PIECES LEFT IN PATIENT.
Patient problems: Foreign Body In Patient; Unspecified Infection
MAUDE report 19757635 ↗InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 13, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryNov 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - POLY SWAP, KNEE WAS GIVING OUT.
Patient problems: Joint Laxity
MAUDE report 18204846 ↗InjuryOct 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO LOOSENING AND PAIN.
Patient problems: Implant Pain; Joint Laxity
MAUDE report 17761634 ↗InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO AN INFECTED KNEE. POOR WOUND HEALING EVENTUALLY LED TO INFECTION. NO FAILURE OF IMPLANTS LED TO INFECTION.
Patient problems: Medical device site infection
MAUDE report 15888432 ↗InjuryNov 4, 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 15739385 ↗InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem
REVISION SURGERY: DUE TO INFECTED TOTAL KNEE ARTHROPLASTY. IRRIGATION AND DRAINAGE POLY SWAP.
Patient problems: Unspecified Infection
MAUDE report 14951969 ↗InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem
REVISION SURGERY: DUE TO AN INFECTION. WASHOUT, REMOVAL OF POLY, RE-IMPLANT OF NEW POLY.
Patient problems: Unspecified Infection
MAUDE report 14250917 ↗InjuryDec 6, 2021Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INFECTION POLY SWAP, WASH OUT WAS DONE.
Patient problems: Bacterial Infection
MAUDE report 12936978 ↗InjurySep 21, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT FELL AND DISLOCATED PATELLA. VASTUS MEDIALIS OBLIQUUS RECONSTRUCTED AND POLY WAS SWAPPED.
Patient problems: Fall; Joint Dislocation
MAUDE report 12505707 ↗InjuryApr 30, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT HAD AN INFECTION, DID A POLY SWAP.
Patient problems: Unspecified Infection
MAUDE report 11758006 ↗InjuryJun 25, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT WAS INFECTED. INSERT WAS REMOVED AS A PRECAUTION AND A NEW ONE WAS INSERTED, WHICH WAS OF THE SAME THICKNESS (12MM).
Patient problems: Unspecified Infection
MAUDE report 10195561 ↗InjuryApr 17, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT FELL AND OPENED WOUND THAT COULD POSSIBLY LEAD TO AN INFECTION.
Patient problems: Fall
MAUDE report 9973158 ↗InjuryAug 27, 2018Unstable
REVISION SURGERY - DUE TO THE PATIENT HAVING FLEXION AND STABILITY ISSUES WITH PAIN. THE SURGEON PULLED OUT IMPLANTS AND LEFT IN THE PATELLA FROM THE FIRST SURGERY. THE SURGEON USED TWO STEMS IN THE REVISION SURGERY. ONE FOR THE TIBIA AND ONE FOR THE FEMUR.
Patient problems: Pain
MAUDE report 7820471 ↗InjuryMar 22, 2018Unstable
REVISION SURGERY - DUE TO THE SURGEON FINDING THAT THE PATIENT HAD INSTABILITY. THE SURGEON REPLACED THE INSERT.
Patient problems: Failure of Implant; No Code Available
MAUDE report 7363205 ↗
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.
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