DJO SURGICAL 341-10-709Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 9L 10MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO Surgical EMPOWR 3D knee instrument is used during knee replacement surgery. The 55 reports mostly describe patients who developed an infection after surgery or an unstable knee, leading to revision surgery, with55 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
- 55
- Deaths reported
- 0
- Injuries reported
- 55
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00888912166867), received between Dec 14, 2017 and Aug 20, 2026 — classified as 55 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 Problem34
- Appropriate Device Problem Term/Code Not Available16
- Unstable6
- Microbial Contamination of Device1
- Naturally Worn1
- No Apparent Adverse Event1
- Patient Device Interaction Problem1
Patient problems
- Unspecified Infection28
- Joint Laxity9
- Fall8
- Insufficient Information5
- Medical device site infection3
- Failure of Implant1
- Implant Pain1
- Muscular Rigidity1
Recent adverse event reports
The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.
InjuryAug 20, 2026No Apparent Adverse Event
Revision surgery - Due to unknown reason.
Patient problems: Insufficient Information
MAUDE report 50358165 ↗InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem
InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO PATIENT PRESENTED WITH INFECTION POST-OP. I&D WITH POLY EXCHANGE WAS DONE.
Patient problems: Unspecified Infection
MAUDE report 25673182 ↗InjuryJun 9, 2026Unstable
InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem
InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem
InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem
POLY SWAP WHILE REVISION TO SOFT TISSUE REPAIR.
Patient problems: Insufficient Information
MAUDE report 24445825 ↗InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem
PATIENT WAS SCHEDULED TO HAVE HARDWARE REMOVED (CANCELLOUS SCREW AND WASHER) AND THE DOCTOR DECIDED TO EXCHANGE THE POLY INSERT AT THE SAME TIME. MALE 54YRS.
Patient problems: Insufficient Information
MAUDE report 24408307 ↗InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
PATIENT PRESENTED TO THE ER THIS A.M. AFTER A FALL DIRECTLY ONTO HIS LEFT KNEE, RESULTING IN A COMPLETE DEHISCENCE OF HIS ARTHROTOMY, AND THE AVULSION OF HIS QUAD TENDON FROM THE PATELLA. AN I&D WITH POLY EXCHANGE AND QUAD TENDON REPAIR WAS COMPLETED.
Patient problems: Fall
MAUDE report 23834917 ↗InjuryJun 24, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 19, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJul 22, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMar 27, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; 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
InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT FELL AND TORE HIS RETINACULUM, SURGEON WENT IN TO CLEAN IT UP AND FOUND AN INFECTION- SURGEON MADE THE DECISION TO SWAP THE INSERT OUT AND GET CULTURES RUN ON THE ORIGINAL POLY INSERT.
Patient problems: Fall; Medical device site infection
MAUDE report 18229380 ↗InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - MDR - HYPERFLEXION/REVISION SURGERY/ REQUIRED INTERVENTION TO PREVENT IMPAIRMENT/DAMAGE.
Patient problems: Insufficient Information
MAUDE report 17946772 ↗InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT FELL AND POPPED OPEN STITCHES.
Patient problems: Insufficient Information; Joint Laxity
MAUDE report 17466434 ↗InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - REQUIRED INTERVENTION TO PREVENT IMPAIRMENT/DAMAGE.
Patient problems: Unspecified Infection
MAUDE report 16542293 ↗
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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