DJO SURGICAL 341-12-705Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 5L 12MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO Surgical EMPOWR 3D knee insert is used in total knee replacement surgery. The 28 reports mostly describe pain, infection, joint looseness and instability after surgery, with several patients needing revision surgery; no deaths were reported and all 28 reports involved an injury. 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
- 28
- Deaths reported
- 0
- Injuries reported
- 28
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00888912166928), received between Feb 4, 2019 and Aug 19, 2026 — classified as 28 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 Problem14
- Appropriate Device Problem Term/Code Not Available7
- Unstable5
- No Apparent Adverse Event2
- Insufficient Device Problem Information1
- Loose or Intermittent Connection1
- Patient Device Interaction Problem1
Patient problems
- Unspecified Infection9
- Joint Laxity5
- Fall3
- Failure of Implant2
- Insufficient Information2
- No Known Impact Or Consequence To Patient2
- Pain2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
InjuryAug 19, 2026No Apparent Adverse Event
Patient problems: Insufficient Information
MAUDE report 50312459 ↗InjuryAug 18, 2026Unstable
Revision Surgery - due to Hyperextension on surgery date (post op event).
Patient problems: Joint Laxity
MAUDE report 50311023 ↗InjuryJun 5, 2026Patient Device Interaction Problem
InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem
InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 9, 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
InjuryMar 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 28, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjurySep 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 30, 2024No Apparent Adverse Event; No Apparent Adverse Event
InjuryApr 13, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PAIN AND INSTABILITY.
Patient problems: Implant Pain; Joint Laxity
MAUDE report 19102534 ↗InjuryJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT HAD POOR RANGE OF MOTION. REMOVAL OF SCAR TISSUE.
Patient problems: Failure of Implant
MAUDE report 18307948 ↗InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 16, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY- DUE TO INSTABILITY.
Patient problems: Insufficient Information
MAUDE report 14718199 ↗InjuryMay 14, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT WAS INFECTED. A WASHOUT AND ORIGINAL TIBIAL INSERT WAS REMOVED AND EXCHANGED.
Patient problems: Unspecified Infection
MAUDE report 14403329 ↗InjuryApr 7, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: DUE TO PATIENT FELL AND INJURED EXTENSOR TENDON, NEEDED A REVISION. POLY WAS SWAPPED TO AVOID INFECTION UPON SECOND OPENING OF WOUND.
Patient problems: Fall
MAUDE report 14044050 ↗InjuryApr 6, 2022Adverse Event Without Identified Device or Use Problem
InjuryMar 17, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: PATIENT FELL AFFECTING THE NEEDLE LEPRO LIGAMENT CAUSING THE JOINT TO GET LOOSE. IMPLANTED A THICKER POLY.
Patient problems: Fall
MAUDE report 13793687 ↗InjuryOct 21, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT WAS EXPERIENCING PAIN AND INSTABILITY.
Patient problems: Pain
MAUDE report 12678265 ↗InjuryJan 6, 2021Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Infection
MAUDE report 11127387 ↗InjurySep 14, 2020Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT WAS INFECTED.
Patient problems: Unspecified Infection
MAUDE report 10528947 ↗InjuryMay 13, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO AN INFECTION. THE IRRIGATION AND DEBRIDEMENT (I&D) WAS PERFORMED.
Patient problems: Unspecified Infection
MAUDE report 8605208 ↗InjuryApr 5, 2019Unstable
REVISION SURGERY - DUE TO INSTABILITY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8487760 ↗
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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