DJO SURGICAL 342-10-704Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 4R 10MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00888912167314), received between Sep 21, 2017 and Sep 28, 2026 — classified as 22 injuries.
The most frequently reported specific device problem is “Unstable” (7 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 Problem9
- Unstable7
- Appropriate Device Problem Term/Code Not Available5
- Insufficient Device Problem Information2
- Loosening of Implant Not Related to Bone-Ingrowth1
- No Apparent Adverse Event1
- Unintended Movement1
- Unintended System Motion1
Patient problems
- Joint Laxity9
- Insufficient Information4
- Pain3
- Failure of Implant2
- Loss of Range of Motion2
- No Code Available2
- Implant Pain1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026No Apparent Adverse Event
Patient problems: Insufficient Information
MAUDE report 50926072 ↗InjuryMay 6, 2026Insufficient Device Problem Information
REVISION SURGERY DUE TO PATELLA TENDON REPAIR / UNKNOWN REVISION REASON.
Patient problems: Insufficient Information
MAUDE report 25107443 ↗InjuryFeb 19, 2026Unintended System Motion
REVISION SURGERY - DUE TO TIGHTENED EXTENSION.
Patient problems: Loss of Range of Motion
MAUDE report 24397534 ↗InjuryJan 30, 2026Loosening of Implant Not Related to Bone-Ingrowth
InjuryJun 4, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 16, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMay 13, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; 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
InjuryOct 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 15, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 21, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY KNEE WAS UNSTABLE.
Patient problems: Insufficient Information
MAUDE report 15077247 ↗InjuryMar 11, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INSTABILITY.
Patient problems: Insufficient Information
MAUDE report 13739832 ↗InjuryNov 22, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO STIFF KNEE. CLEANED THE BACK OF THE JOINT & PUT IN A NEW POLY.
Patient problems: Loss of Range of Motion
MAUDE report 12853486 ↗InjuryFeb 10, 2021Unstable
REVISION SURGERY - THE PATIENT COMPLAINED OF INSTABILITY AND PAIN. SHE REQUESTED TO HAVE REVISION SURGERY.
Patient problems: Failure of Implant; Pain
MAUDE report 11307545 ↗InjuryAug 21, 2020Appropriate Device Problem Term/Code Not Available
InjuryOct 23, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INSTABILITY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9226101 ↗InjuryApr 3, 2018Unintended Movement
REVISION SURGERY - DUE TO SUBLUXING. THE PATIENT WAS EXPERIENCING PAIN.
Patient problems: Failure of Implant; No Code Available; Pain
MAUDE report 7393854 ↗InjuryNov 6, 2017Unstable
REVISION SURGERY - INSTABILITY DUE TO SCAR TISSUE.
Patient problems: No Code Available; Scar Tissue
MAUDE report 7003138 ↗InjurySep 21, 2017Insufficient Device Problem Information
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 6884938 ↗
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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