DJO SURGICAL 241-02-104Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM FEMUR, NP, 4R · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888912166713), received between Aug 12, 2021 and Apr 22, 2026 — classified as 9 injuries.
The most frequently reported specific device problem is “Unstable” (3 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 Problem7
- Unstable3
- Appropriate Device Problem Term/Code Not Available1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Joint Laxity4
- Insufficient Information3
- Bone Fracture(s)1
- Inflammation1
- Loss of Range of Motion1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryApr 22, 2026Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY DUE TO PATIENT'S FEMORAL COMPONENT WAS LOOSE.
Patient problems: Joint Laxity
MAUDE report 24961037 ↗InjuryDec 16, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
UNSPECIFIED REVISION.
Patient problems: Insufficient Information; Joint Laxity
MAUDE report 23824456 ↗InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 5, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryApr 17, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO LOSS OF RANGE OF MOTION.
Patient problems: Loss of Range of Motion
MAUDE report 21858226 ↗InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; 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
"REVISION" SURGERY - DUE TO UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 19767980 ↗InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO ORIGINAL TKR DONE BY DR. (B)(6) DIAGNOSED PATELLAR TRACKING ISSUE NEEDS TO BE ADDRESSED BY A REVISION TKR DUE TO FEMORAL COMPONENT MAL ROTATION AND REVISION OF PATELLAR RESECTION CUT. DR. REMOVED THE FEMORAL COMPONENT, TIBIAL INSERT AND PATELLA COMPONENT. HE CORRECTED THE FEMORAL ROTATION AND IMPLANTED A REVISION FEMORAL COMPONENT AND STEM EXTESION. HE CORRECTED THE PATELLA RESCTION WITH A NEW CUT AND REPLACED THE PATELLA. HE USED A VVC INSERT WHICH PROVIDED THE BEST STABILITY.
Patient problems: Insufficient Information; Joint Laxity
MAUDE report 19368051 ↗InjuryAug 12, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO PAIN AND SWELLING OF RIGHT KNEE POST TOTAL KNEE ARTHROPLASTY.
Patient problems: Inflammation; Pain
MAUDE report 12316686 ↗
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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