DJO SURGICAL 342-10-708Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 8R 10MM, VE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is an Encore Medical EMPOWR 3D knee joint insert used during total knee replacement surgery. The 62 reports mostly describe knees that became painful, loose or unstable, sometimes with infection, and several patients needing a second operation to remove or swap out the plastic insert. There were no deaths, and all 62 reports involved injuries. 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
- 58
- Deaths reported
- 0
- Injuries reported
- 58
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00888912167352), received between Nov 10, 2017 and Sep 28, 2026 — classified as 58 injuries.
The most frequently reported specific device problem is “Unstable” (8 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 Problem35
- Appropriate Device Problem Term/Code Not Available14
- Unstable8
- Insufficient Device Problem Information3
- Inadequacy of Device Shape and/or Size2
- Device Dislodged or Dislocated1
- Improper or Incorrect Procedure or Method1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Unspecified Infection29
- Joint Laxity11
- Insufficient Information4
- Fall3
- No Code Available3
- Impaired Healing2
- Implant Pain2
- Medical device site infection2
Recent adverse event reports
The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Device Dislodged or Dislocated
Patient problems: Unspecified Infection
MAUDE report 50926529 ↗InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem
InjuryMay 26, 2026Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY DUE TO PATIENT'S KNEE WAS LOOSE AND UNSTABLE THE 10MM POLY WAS REMOVED AND SIZED UP TO A 12MM INSERT.
Patient problems: Joint Laxity
MAUDE report 25294060 ↗InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem
InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD AN INFECTION. DOCTOR DID A WASH OUT AND REPLACED THE POLY.
Patient problems: Unspecified Infection
MAUDE report 24974245 ↗InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem
PATIENT INFECTED SO DID A WASHOUT AND POLY SWAP.
Patient problems: Unspecified Infection
MAUDE report 24837581 ↗InjuryMar 14, 2026Unstable
InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem
InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INFECTION/POLY SWAP.
Patient problems: Unspecified Infection
MAUDE report 23927519 ↗InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HAD AN INFECTION SHORTLY AFTER SURGERY WHICH CAUSED HER TO HAVE AN ABX SPACER PLACED AND SUBSEQUENT REVISION TO RE-IMPLANT. 65YRS FEMALE.
Patient problems: Unspecified Infection
MAUDE report 23857992 ↗InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
REVISION SURGERY - THE PATIENT TORE HIS QUAD TENDON. THE SURGEON WANTED TO DO A POLY SWAP ALONG WITH HIS QUAD TENDON REPAIR.
Patient problems: Insufficient Information
MAUDE report 23297654 ↗InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT FELL LESS THAN A WEEK AFTER SURGERY AND RE-OPENED HER INCISION. THE SURGEON WAS CONCERNED ABOUT INFECTION AND WASHED HER OUT AND SWAPPED THE POLY.
Patient problems: Fall; Unspecified Infection
MAUDE report 23012367 ↗InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 23, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO 10MM POLY INSERT, JOINT LAXITY.
Patient problems: Joint Laxity
MAUDE report 22312009 ↗InjuryJun 16, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMay 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 11, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO LOOSENING OF THE TIBIAL COMPONENT.
Patient problems: Implant Pain; Joint Laxity
MAUDE report 20909376 ↗InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 23, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO WASHOUT KNEE AND EXCHANGE POLY.
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 19564303 ↗
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 13, 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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