DJO SURGICAL 342-14-709Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 9R 14MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888912167567), received between Apr 22, 2019 and Sep 24, 2026 — classified as 15 injuries.
The most frequently reported specific device problem is “Unstable” (4 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 Problem8
- Unstable4
- Appropriate Device Problem Term/Code Not Available3
- Insufficient Device Problem Information1
- Loose or Intermittent Connection1
Patient problems
- Joint Laxity5
- Unspecified Infection5
- Implant Pain2
- Insufficient Information2
- Fall1
- Hematoma1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50891993 ↗InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem
InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem
InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO SURGEON WANTED TO SWAP POLY DUE TO LARGE HEMATOMA.
Patient problems: Hematoma
MAUDE report 21309252 ↗InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 3, 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 18441354 ↗InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY : FALL LOWER BODY COMPONENT.
Patient problems: Insufficient Information
MAUDE report 16812027 ↗InjuryApr 13, 2023Unstable; 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 16735227 ↗InjuryOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT WAS UNSTABLE. SURGEON DID A POLY EXCHANGE AND WAS HAPPY WITH TRACKING.
Patient problems: Joint Laxity
MAUDE report 15595722 ↗InjuryApr 29, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY, DUE TO POLY SWAP.
Patient problems: Insufficient Information
MAUDE report 14250945 ↗InjuryApr 11, 2022Unstable
REVISION SURGERY - THE PATIENT HAD GLOBAL INSTABILITY WITH 14MM INSERT. SURGEON REMOVED THE 14MM AND WENT TO A 19MM.
Patient problems: Joint Laxity
MAUDE report 14074327 ↗InjuryJun 14, 2021Insufficient Device Problem Information
REVISION SURGERY - PATIENT PRESENTED OVER A YEAR POST OPERATION WITH AN INFECTION. SURGEON HAD TO REPLACE POLY DURING CLEAN OUT OF THE SITE.
Patient problems: Unspecified Infection
MAUDE report 11996814 ↗InjuryApr 29, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATIENT HAD AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10010247 ↗InjuryJun 13, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT FALLING TWO WEEKS POST-OP AFTER A TOTAL KNEE ARTHROPLASTY. THE SURGEON PERFORMED AN INSERT EXCHANGE AND WASH OUT. PATIENT SHOULD RECOVER NORMALLY.
Patient problems: Fall
MAUDE report 8696467 ↗InjuryApr 22, 2019Loose or Intermittent Connection
REVISION SURGERY - DUE TO THE KNEE BEING TOO LOOSE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8538168 ↗
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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