DJO SURGICAL 341-10-708Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 8L 10MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Encore Medical EMPOWR 3D knee implant is used in total knee replacement surgery. The 59 reports mostly describe knee instability or looseness, along with infection, joint laxity and pain, often leading to revision surgery to swap the plastic insert or re-fix a loose tibial component. There are 59 injuries and no deaths, and 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
- 61
- Deaths reported
- 0
- Injuries reported
- 61
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 00888912166850), received between Oct 28, 2016 and Sep 25, 2026 — classified as 61 injuries.
The most frequently reported specific device problem is “Unstable” (12 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 Problem39
- Unstable12
- Appropriate Device Problem Term/Code Not Available8
- No Apparent Adverse Event2
- Device Dislodged or Dislocated1
- Device Operates Differently Than Expected1
- Insufficient Device Problem Information1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Unspecified Infection26
- Joint Laxity14
- Insufficient Information6
- Implant Pain4
- Failure of Implant3
- Pain3
- Loss of Range of Motion2
- No Code Available2
Recent adverse event reports
The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Patient Device Interaction Problem
Patient problems: Pain
MAUDE report 50905481 ↗InjuryAug 21, 2026No Apparent Adverse Event
Revision surgery - Due to unknown revision reason / Poly Swap.
Patient problems: Insufficient Information
MAUDE report 50360572 ↗InjuryJul 8, 2026No Apparent Adverse Event
REVISION SURGERY - REQUEST FOR POLY SWAP, UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 25755522 ↗InjuryApr 24, 2026Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO PHYSICIAN STATING THAT THE PATIENT NEEDED A PATELLA RESURFACING AND POLY EXCHANGE FOR INSTABILITY/PATELLA PAIN.
Patient problems: Joint Laxity; Pain
MAUDE report 24990886 ↗InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem
InjuryMar 5, 2026Adverse Event Without Identified Device or Use Problem
TIBIAL REVISION FOR LOOSE/UNSTABLE CEMENTLESS TIBIA.
Patient problems: Joint Laxity
MAUDE report 24520951 ↗InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - RESURFACE THE PATELLA AND SWITCH THE POLY TO A THICKER ONE, UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 24492391 ↗InjuryFeb 17, 2026Unstable
InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem
InjuryDec 2, 2025Unstable; Unstable
InjuryOct 21, 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 DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 23353613 ↗InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT REQUIRED REVISION SURGERY DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 23044787 ↗InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY: DUE TO POLY WAS TOO TIGHT. SURGEON DID SOME RELEASES AND REPLACED WITH EXACT SIZE POLY.
Patient problems: Loss of Range of Motion
MAUDE report 21748996 ↗InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 12, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO PAIN AND LOOSENING.
Patient problems: Implant Pain; Joint Laxity
MAUDE report 20530225 ↗InjuryOct 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 23, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY: DUE TO WASHED OUT AND CHANGED POLY, CAME INTO ER WITH BRUISING AND HEMATOMA.
Patient problems: Hematoma
MAUDE report 19235498 ↗
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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