DJO SURGICAL 341-12-708Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 8L 12MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO Surgical EMPOWR 3D knee implant is used in total knee replacement surgery. The 39 adverse event reports mostly describe repeat (revision) surgery on the knee, most often because of infection, along with falls and joint looseness that reopened or strained the surgical wound. No deaths were reported; all 39 reports involved injuries. 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
- 40
- Deaths reported
- 0
- Injuries reported
- 40
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00888912166959), received between Jan 9, 2017 and Sep 23, 2026 — classified as 40 injuries.
The most frequently reported specific device problem is “Unstable” (6 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 Problem28
- Appropriate Device Problem Term/Code Not Available6
- Unstable6
- Insufficient Device Problem Information2
- Fracture1
- Output Problem1
Patient problems
- Unspecified Infection26
- Fall5
- Joint Laxity4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Insufficient Information2
- Bone Fracture(s)1
- Failure of Implant1
- Medical device site infection1
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50862968 ↗InjuryJul 20, 2026Adverse Event Without Identified Device or Use Problem
InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem
InjuryJan 19, 2026Adverse Event Without Identified Device or Use Problem
InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT FELL POSTOPERATIVELY AND OPENED HIS SURGICAL WOUND.
Patient problems: Fall
MAUDE report 24063622 ↗InjuryOct 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 23333907 ↗InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT FELL AND RUPTURED THEIR EXTENSOR MECHANISM IN THE KNEE. SO JUST DID A POLY SWAP.
Patient problems: Fall
MAUDE report 22181173 ↗InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 24, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryOct 21, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - FALL LOWER BODY & INFECTION.
Patient problems: Unspecified Infection
MAUDE report 18044499 ↗InjurySep 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - MDR - FALL LOWER BODY COMPONENT AND INFECTION.
Patient problems: Fall; Unspecified Infection
MAUDE report 17176076 ↗InjuryApr 10, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; 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
InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT WAS UNSTABLE AND NEEDED A LONGER POLY.
Patient problems: Joint Laxity
MAUDE report 15670374 ↗InjuryOct 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - INFECTED KNEE WASHOUT, POLY EXCHANGE.
Patient problems: Medical device site infection
MAUDE report 15544685 ↗InjuryAug 17, 2022Unstable
REVISION SURGERY - KNEE WAS UNSTABLE. PUT IN THICKER POLY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15243459 ↗InjuryJun 9, 2022Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT HAS FALLEN ON KNEE AND SURGEON WANTED TO SWAP POLY.
Patient problems: Fall
MAUDE report 14646001 ↗
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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