DJO SURGICAL 341-16-706Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 6L 16MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888912167130), received between Dec 19, 2018 and Jun 11, 2026 — classified as 13 injuries.
The most frequently reported specific device problem is “Unstable” (2 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 Problem12
- Unstable2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Unspecified Infection6
- Joint Laxity3
- Fall2
- Discomfort1
- Insufficient Information1
- Pain1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem
InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - POLY SWAP, DUE TO UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 25010678 ↗InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY: DUE TO PATIENT FELL SHORTLY AFTER POSTOP. SURGEON WANTED TO CONFIRM NO IMPLANTS HAD LOOSENED.
Patient problems: Fall
MAUDE report 22800988 ↗InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 12, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJan 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 10, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 13, 2021Appropriate Device Problem Term/Code Not Available
SECOND REVISION SURGERY - INSTABILITY FROM FALLING IN PHYSICAL THERAPY, NEEDS A POST FROM EXPERT POLY INSTEAD OF 3D.
Patient problems: Fall
MAUDE report 11163288 ↗InjuryAug 18, 2020Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - POSSIBLE INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10420285 ↗InjuryDec 19, 2018Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT COMPLAINING OF PAIN AND DISCOMFORT.
Patient problems: Discomfort; Pain
MAUDE report 8182320 ↗
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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