DJO SURGICAL 342-10-705Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 5R 10MM, VE · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Encore Medical EMPOWER 3D knee insert is used in total knee replacement surgery. The 50 reports mostly describe a loose or unstable knee after surgery, with some patients needing a second operation to replace or resize the insert; others mention infection or pain. There are no deaths and 50 injuries. One open recall, started in August 2023, covers knee and hip parts being swapped in the inner package before sealing, so surgeons could open the wrong implant.
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
- 51
- Deaths reported
- 0
- Injuries reported
- 51
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00888912167321), received between Nov 19, 2016 and Sep 30, 2026 — classified as 51 injuries.
The most frequently reported specific device problem is “Unstable” (15 reports).
1 FDA recall record name this device's identifier, 1 still open.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Aug 22, 2023Open, Classified
Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).
Z-0102-2024 · Root cause: Labeling Change Control · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem25
- Unstable15
- Appropriate Device Problem Term/Code Not Available11
- Device Dislodged or Dislocated2
- Insufficient Device Problem Information2
- Contamination of Device Ingredient or Reagent1
- Detachment of Device or Device Component1
- Inadequacy of Device Shape and/or Size1
Patient problems
- Unspecified Infection14
- Joint Laxity10
- Insufficient Information8
- No Known Impact Or Consequence To Patient4
- Fall3
- No Code Available3
- Failure of Implant2
- Implant Pain2
Recent adverse event reports
The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50941453 ↗InjuryAug 19, 2026No Apparent Adverse Event
Patient problems: Insufficient Information
MAUDE report 50312452 ↗InjuryJun 11, 2026Unstable
InjuryMay 19, 2026Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY DUE TO PATIENT WAS LOOSE IN MID-FLEXION, NEEDED THICKER INSERT.
Patient problems: Joint Laxity
MAUDE report 25225292 ↗InjuryMay 8, 2026Detachment of Device or Device Component
THE POLY HAD NOT LOCKED INTO THE TIBIAL BASEPLATE SO WE HAD TO REMOVE AND REINSERT A NEW POLY.
Patient problems: Failure of Implant
MAUDE report 25129483 ↗InjuryApr 22, 2026Patient Device Interaction Problem
REVISION SURGERY - DUE TO THE PATIENT WAS COMPLAINING OF PAIN. OPTED A REVISION SURGERY TO RESURFACE HER PATELLA (THIS WAS NOT DONE ON HER PRIMARY SURGERY) AND TO REPLACE HER INSERT WITH A THICKER SIZE.
Patient problems: Implant Pain
MAUDE report 24958573 ↗InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem
THIS PATIENT HAD A LEFT TKR ON DATE AND RIGHT TKR ON DATE. THE PATIENT PRESENTED WITH BILATEAL ACUTE INFECTIONS IN BOTH KNEES. DR. DID A BILATERAL I&D AND TIBIAL INSERT EXCHANGE. FEMALE 72.
Patient problems: Unspecified Infection
MAUDE report 24706160 ↗InjuryFeb 23, 2026Unintended System Motion
REVISION SURGERY - DUE TO PATIENT WAS UNABLE TO BEND THE KNEE.
Patient problems: Loss of Range of Motion
MAUDE report 24424158 ↗InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - UPSIZING THE POLY THICKNESS, UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 24373549 ↗InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO TWO DAYS AFTER SURGERY, THE PATIENT FELL AND FRACTURED HER FEMUR.
Patient problems: Bone Fracture(s); Fall
MAUDE report 24319144 ↗InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PERIPROSTHETIC FRACTURE OCCURRED DURING MANIPULATION, WHICH REQUIRED A RETROGRADE NAIL AND A POLYETHYLENE SWAP.
Patient problems: Periprosthetic fracture
MAUDE report 23295401 ↗InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO REVISED PATELLA FOR UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 22024610 ↗InjuryOct 14, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjurySep 14, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjurySep 11, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 24, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryOct 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - NO PATELLA IN PATIENT. PATELLA WAS ADDED TO KNEE IMPLANTS.
Patient problems: Insufficient Information
MAUDE report 17936625 ↗InjurySep 8, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryAug 22, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryAug 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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 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
- NA 323.26Synthes GmbH · Guide, surgical, instrument64 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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