DJO SURGICAL 241-01-105Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM FEMUR, NP, 5L · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888912166621), received between Oct 23, 2019 and Sep 22, 2026 — classified as 13 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 Problem9
- Device Dislodged or Dislocated2
- Appropriate Device Problem Term/Code Not Available1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Unstable1
Patient problems
- Fall4
- Joint Dislocation3
- Joint Laxity3
- Insufficient Information2
- Arthralgia1
- Bone Fracture(s)1
- Failure of Implant1
- Implant Pain1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
InjurySep 22, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50862492 ↗InjuryApr 17, 2026Device Dislodged or Dislocated
REVISION SURGERY - DUE TO PATIENT HAD A FALL AND DISLOCATED.
Patient problems: Fall; Joint Dislocation
MAUDE report 24918862 ↗InjuryFeb 19, 2026Loosening of Implant Not Related to Bone-Ingrowth
InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DR WANTED TO CONVERT TO A PS KNEE SO HE TOOK OUT THE EMPOWER 3D FEMUR AND INSERT.
Patient problems: Insufficient Information
MAUDE report 18178883 ↗InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - REQUIRED INTERVENTION TO PREVENT IMPAIRMENT/DAMAGE.
Patient problems: Failure of Implant
MAUDE report 17212526 ↗InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - REQUIRED INTERVENTION TO PREVENT IMPAIRMENT/DAMAGE.
Patient problems: Insufficient Information
MAUDE report 16236603 ↗InjuryDec 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT FELL, FRACTURED DISTAL FEMUR, COMPETITOR PRODUCT WAS IMPLANTED.
Patient problems: Bone Fracture(s); Fall
MAUDE report 16077587 ↗InjuryDec 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - SPACER TO REVISION TOTAL KNEE ARTHROPLASTY.
Patient problems: Arthralgia
MAUDE report 16026886 ↗InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT WAS LOOSE IN FLEXION.
Patient problems: Joint Laxity
MAUDE report 15634097 ↗InjuryOct 23, 2019Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT FELL AND DISLOCATED HER KNEE.
Patient problems: Fall; Joint Dislocation
MAUDE report 9226102 ↗
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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