DJO SURGICAL 341-14-705Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 5L 14MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00888912167024), received between Aug 22, 2018 and Apr 23, 2026 — classified as 17 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 Problem9
- Appropriate Device Problem Term/Code Not Available5
- Unstable5
- Device Dislodged or Dislocated1
- Inadequacy of Device Shape and/or Size1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Joint Laxity7
- Unspecified Infection5
- Pain2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Code Available1
- No Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem
InjuryFeb 12, 2026Loosening of Implant Not Related to Bone-Ingrowth
InjuryMay 1, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJan 15, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 18, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 15, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryDec 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT WAS EXPERIENCING PAIN AND INSTABILITY.
Patient problems: Joint Laxity; Pain
MAUDE report 16061779 ↗InjuryFeb 14, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO TIGHTNESS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13522884 ↗InjuryJun 3, 2021Appropriate Device Problem Term/Code Not Available
InjuryJul 16, 2020Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT DISLOCATED PATELLA. POLY WAS REMOVED AND REPLACED DURING SURGERY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10282892 ↗InjuryJan 10, 2020Inadequacy of Device Shape and/or Size
REVISION SURGERY PATIENT PRESENTED TO SURGEON WITH PAIN. HE FELT A THICKER INSERT SHOULD BE USED.
Patient problems: Pain
MAUDE report 9574659 ↗InjurySep 6, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY- PATIENT PRESENTED WITH POSSIBLE INFECTION. INSERT REMOVED AND REPLACED AFTER WASHOUT / ANTIBIOTICS.
Patient problems: Unspecified Infection
MAUDE report 8970957 ↗InjuryFeb 26, 2019Appropriate Device Problem Term/Code Not Available
InjuryAug 22, 2018Unstable
REVISION SURGERY - DUE TO THE PATIENT BEING UNSTABLE IN BOTH FLEXION AND EXTENSION. THE SURGEON WENT FROM A 14 MILLIMETER TO A 19 MILLIMETER INSERT.
Patient problems: No Code Available
MAUDE report 7807136 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page