DJO SURGICAL 341-10-710Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 10L 10MM, VE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Encore Medical EMPORR 3D 10mm insert is used in knee replacement surgery. The 31 reports describe knee instability, infections, joint pain and loosening, with several patients needing revision surgery after falls or infection; all 31 reports involved injuries 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
- 31
- Deaths reported
- 0
- Injuries reported
- 31
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00888912166874), received between Dec 5, 2017 and Mar 26, 2026 — classified as 31 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem17
- Appropriate Device Problem Term/Code Not Available11
- Unstable5
- Insufficient Device Problem Information1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Unexpected Therapeutic Results1
Patient problems
- Unspecified Infection11
- Joint Laxity6
- Pain4
- Hemorrhage/Blood Loss/Bleeding3
- Insufficient Information2
- Fall1
- Loss of Range of Motion1
- Medical device site infection1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
InjuryMar 26, 2026Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem
InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem
InjuryJan 7, 2026Unstable
InjuryOct 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY FOR POLY LINER SWAP.
Patient problems: Insufficient Information
MAUDE report 23333909 ↗InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
InjuryMay 3, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMar 7, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJan 22, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT WAS EXPERIENCING KNEE PAIN. THE EXISTING POLY WAS REMOVED AND REPLACED WITH A 11MM POLY. THE PATELLA WAS ALSO RESURFACED AND A PATELLA POLY WAS IMPLANTED.
Patient problems: Pain
MAUDE report 18229389 ↗InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO FALL, LOWER BODY / INFECTION / SERIOUS RISK TO PATIENT.
Patient problems: Unspecified Infection
MAUDE report 16587430 ↗InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Medical device site infection
MAUDE report 15970213 ↗InjuryNov 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT WAS COMPLAINING OF PAIN AND LACK OF RANGE OF MOTION.
Patient problems: Loss of Range of Motion; Pain
MAUDE report 15810421 ↗InjuryMay 11, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO BLEEDING AFTER PRIMARY SURGERY.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 14364819 ↗InjuryApr 18, 2022Unexpected Therapeutic Results
REVISION SURGERY - THE PATIENT WAS HAVING SOME INSTABILITY AND SLIGHT PAIN IN THE MID FLEXION, IN ACTIVITIES LIKE WALKING DOWNSTAIRS OR DOWNHILL. SURGEON REMOVED A 10MM POLY AND REPLACED WITH 14MM.
Patient problems: Joint Laxity; Pain
MAUDE report 14137591 ↗InjuryJan 7, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO POST OPERATIVE ANTERIOR KNEE PAIN.
Patient problems: Pain
MAUDE report 13198896 ↗InjuryDec 30, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 13123009 ↗InjuryNov 29, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INFECTED KNEE. SWAPPED POLY AFTER CLEANING.
Patient problems: Unspecified Infection
MAUDE report 12882832 ↗InjuryJul 30, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INFECTION WITH A POLY SWAP AND WASH OUT.
Patient problems: Insufficient Information
MAUDE report 12254796 ↗InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem
InjuryJan 5, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAD INFECTION. REMOVED AND REPLACED THE INSERT.
Patient problems: Unspecified Infection
MAUDE report 11120441 ↗InjurySep 1, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - INTERNAL BLEEDING.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 10476868 ↗InjuryJun 17, 2020Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10163148 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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