DJO SURGICAL 342-12-708Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 8R 12MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Encore Medical EMPOWR 3D knee implant insert is used in knee replacement surgery. The 34 reports mostly describe repeat revision surgery to remove and replace the insert, with the stated reasons including infection, instability or partial dislocation of the joint, a fall that reopened the incision, and cases where the reason was not stated. All 34 reports involved injuries, and no deaths were reported. There are no recalls naming 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
- 32
- Deaths reported
- 0
- Injuries reported
- 32
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00888912167451), received between Dec 21, 2017 and Jul 16, 2026 — classified as 32 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 Problem19
- Unstable5
- Appropriate Device Problem Term/Code Not Available4
- Device Dislodged or Dislocated3
- No Apparent Adverse Event2
- Contamination1
- Material Too Rigid or Stiff1
- Physical Resistance/Sticking1
Patient problems
- Unspecified Infection10
- Insufficient Information7
- Joint Laxity7
- No Code Available3
- Failure of Implant2
- Joint Dislocation2
- Fall1
- Implant Pain1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
InjuryJul 16, 2026No Apparent Adverse Event
REVISION SURGERY - REMOVED WOUND VAC, WASHED OUT AGAIN, AND REPLACED THE POLY./UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 25849271 ↗InjuryJun 14, 2026Adverse Event Without Identified Device or Use Problem
InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO PATIENT IS INFECTED ONE MONTH POST OP.
Patient problems: Unspecified Infection
MAUDE report 25075539 ↗InjuryMar 12, 2026Unstable; Device Dislodged or Dislocated
REVISION SURGERY - DUE TO SUBLUXATION.
Patient problems: Joint Dislocation; Joint Laxity
MAUDE report 24586027 ↗InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem
InjuryNov 18, 2025Unstable; Unstable
InjuryAug 25, 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
REVISION SURGERY - DUE TO UNKNOWN POLY ISSUE.
Patient problems: Insufficient Information
MAUDE report 22372574 ↗InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 12, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryNov 11, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJun 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO TIBIA DID NOT INGROW - WE HAD TO REMOVE THE FEMUR TO GET THE TIBIA COMPONENT OUT
Patient problems: Insufficient Information
MAUDE report 19580657 ↗InjuryMay 22, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMay 15, 2024No Apparent Adverse Event; No Apparent Adverse Event
REVISION SURGERY - DUE TO PATELLAR TENDON REPAIR.
Patient problems: Insufficient Information
MAUDE report 19320362 ↗InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT HAD A TOTAL KNEE DONE. SURGEON WENT BACK IN TO RESURFACE THE PATELLA.
Patient problems: Insufficient Information
MAUDE report 19029791 ↗InjuryFeb 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 21, 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
InjuryJan 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT FELT LIKE THERE WAS TOO MUCH "PLAY" IN THE KNEE JOINT, SO THE SURGEON IMPLANTED A LARGER INSERT.
Patient problems: Joint Laxity
MAUDE report 15572963 ↗InjuryJul 28, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - POSSIBLE INFECTION.
Patient problems: Unspecified Infection
MAUDE report 15126687 ↗InjuryJun 29, 2022Device Dislodged or Dislocated
REVISION SURGERY - DUE TO INSTABILITY AND POLY SWAP.
Patient problems: Failure of Implant
MAUDE report 14856432 ↗InjuryJun 21, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INSTABILITY. REPLACED SIZE 8X12 POLY WITH 8X16.
Patient problems: Insufficient Information
MAUDE report 14758045 ↗
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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