DJO SURGICAL 342-12-705Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 5R 12MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Encore EMPOWR knee insert is a plastic part used in knee replacement surgery. The 26 reports describe follow-up revision surgeries for infections and knee instability, including loose joints, falls and dislocation, with 26 injuries mentioned and no deaths. 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
- 26
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00888912167420), received between May 22, 2018 and May 18, 2026 — classified as 26 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 Problem19
- Appropriate Device Problem Term/Code Not Available5
- Unstable5
- Device Dislodged or Dislocated1
- Insufficient Device Problem Information1
Patient problems
- Unspecified Infection12
- Joint Laxity9
- Fall3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Implant Pain1
- Joint Dislocation1
- Muscular Rigidity1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.
InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO POSSIBLE INFECTION; KNEE DEBRIMENT. INSERT ANOTHER POLY INSERT.
Patient problems: Unspecified Infection
MAUDE report 25211553 ↗InjuryApr 7, 2026Unstable; Device Dislodged or Dislocated
REVISION SURGERY - DUE TO FALL, INSTABILITY AND DISLOCATION.
Patient problems: Fall; Joint Dislocation; Joint Laxity
MAUDE report 24808650 ↗InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem
InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - INFECTION DUE TO A FALL.
Patient problems: Fall; Unspecified Infection
MAUDE report 24477831 ↗InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT FELL AND OPENED HER WOUND FROM PRIOR SURGERY 3 DAYS PRIOR. NEEDED WASHOUT AND POLY INSERT EXCHANGE.
Patient problems: Fall; Unspecified Infection
MAUDE report 22128592 ↗InjuryFeb 12, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 11, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - INFECTED TOE NAIL LEAD TO INFECTION ONE YEAR POST OP.
Patient problems: Joint Laxity
MAUDE report 18323655 ↗InjurySep 25, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjurySep 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 26, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMay 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT WAS HAVING WOUND HEALING ISSUES AND GOT A WASHOUT AND INSERT EXCHANGE.
Patient problems: Wound Dehiscence
MAUDE report 15478723 ↗InjuryApr 20, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 14160857 ↗InjuryJan 20, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: SURGEON EXCHANGE POLY INSERT DUE TO GLOBAL STIFFNESS IN THE JOINT.
Patient problems: Muscular Rigidity
MAUDE report 13311670 ↗InjurySep 17, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - INFECTION WITH WASHOUT AND POLY SWAP.
Patient problems: Unspecified Infection
MAUDE report 12492089 ↗InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT HAD AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 11776850 ↗InjurySep 29, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - SURGEON TOOK THE PATIENT BACK FOR AN IRRIGATION & DRAINAGE, WASHOUT AND EXCHANGED THE POLY SURFACE FOR A NEW ONE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 10600323 ↗InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO POSSIBLE INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10580158 ↗InjuryApr 12, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT NOT HAVING THE PATELLA RESURFACED. THE SURGEON RESURFACED AND DECIDED TO CHANGE OUT THE INSERT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8510929 ↗
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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