DJO SURGICAL 241-01-106Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM FEMUR, NP, 6L · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 1
- Injuries reported
- 13
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00888912166638), received between Apr 22, 2019 and Jun 3, 2026 — classified as 1 death, 13 injuries.
The most frequently reported specific device problem is “Unstable” (5 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 Problem9
- Unstable5
- Appropriate Device Problem Term/Code Not Available3
- Loosening of Implant Not Related to Bone-Ingrowth1
- Patient Device Interaction Problem1
Patient problems
- Failure of Implant5
- Joint Laxity4
- Implant Pain2
- Aseptic loosening1
- Fall1
- Insufficient Information1
- Pain1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem
InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
InjuryDec 8, 2025Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth
THE PATIENT EXPERIENCED FEMORAL COMPONENT LOOSENING WITH A CEMENTED IMPLANT WITHIN 1 YEAR POST OP. F/57.
Patient problems: Aseptic loosening; Joint Laxity
MAUDE report 23743295 ↗InjuryOct 15, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, DUE TO INSTABILITY, THE PATIENT REQUIRED REVISION SURGERY.
Patient problems: Joint Laxity
MAUDE report 23301177 ↗InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO UNKNOWN REVISION REASON, FEMUR ONLY REVISION.
Patient problems: Insufficient Information
MAUDE report 21735596 ↗InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DeathAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2023 FROM "EXSANGUINATION DUE TO LACERATION OF THE LEFT POPLITEAL ARTERY, DUE TO MECHANICAL FAILURE OF LEFT PROSTHETIC KNEE JOINT."
Patient problems: Failure of Implant
MAUDE report 19965576 ↗InjuryMar 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO RE-IMPLANT FROM SPACER.
Patient problems: Failure of Implant
MAUDE report 16570217 ↗InjuryApr 11, 2022Unstable
InjuryApr 15, 2021Unstable; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATIENT HAD MID-FLEXION INSTABILITY.
Patient problems: Failure of Implant
MAUDE report 11671354 ↗InjuryAug 13, 2019Unstable; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: AFTER REPEATED STABILITY ISSUES. THE SURGEON DECIDED TO REVISE THE FEMORAL COMPONENT ONLY AS TO AVOID DAMAGE TO THE TIBIA.
Patient problems: Failure of Implant
MAUDE report 8890591 ↗InjuryApr 22, 2019Appropriate Device Problem Term/Code Not Available
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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