DJO SURGICAL 342-10-709Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 9R 10MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO Surgical 3D knee implant guides surgery on the knee joint. The 64 reports describe the implant feeling unstable or shifting in the knee, along with infections that led to revision surgery, plus joint looseness and pain. No deaths were reported, and all 64 reports describe injuries. No recalls name this device, and report numbers over the last 12 months are similar to the prior period.
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
- 62
- Deaths reported
- 0
- Injuries reported
- 62
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00888912167369), received between Mar 13, 2017 and Jul 27, 2026 — classified as 62 injuries.
The most frequently reported specific device problem is “Unstable” (7 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 Problem36
- Appropriate Device Problem Term/Code Not Available18
- Unstable7
- Insufficient Device Problem Information3
- Loose or Intermittent Connection2
Patient problems
- Unspecified Infection36
- Joint Laxity11
- Insufficient Information6
- Fall2
- Muscle/Tendon Damage2
- No Code Available2
- Pain2
- Implant Pain1
Recent adverse event reports
The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
InjuryJun 5, 2026Unstable
InjuryApr 20, 2026Unstable
InjuryDec 10, 2025Unstable; Unstable
INSTABILITY. REMOVED POLY AND WENT TO A THICKER POLY.
Patient problems: Joint Laxity
MAUDE report 23774435 ↗InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 7, 2025Unstable; Unstable
InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO 3 DAYS POST OP PATIENT FELL IN THE SHOWER AND RIPPED HIS REPAIR. DR WASHED HIM OUT AND REPLACED THE POLY.
Patient problems: Insufficient Information
MAUDE report 19736592 ↗InjuryJun 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT FELL AND RUPTURED HER INCISION.
Patient problems: Insufficient Information
MAUDE report 19640120 ↗InjuryMay 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT FELL IN THE SHOWER AND RIPPED OPEN THE OPERATIVE KNEE. DOCTOR DID AN I&D AND REPLACED THE POLY WITH THE SAME THICKNESS.
Patient problems: Muscle/Tendon Damage
MAUDE report 19244325 ↗InjuryApr 16, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PT WENT TO ER AFTER A FALL. LIGAMENTS IN KNEE APPEARED TO BE TORN. SURGEON REMOVED POLY AND PACKED WITH ANTIBIOTICBEADS. RETURNED ON 3/4 TO INSERT LARGER SPACER TO IMPROVE JOINT STABILITY.
Patient problems: Joint Laxity; Muscle/Tendon Damage
MAUDE report 19029774 ↗InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT WAS TOO TIGHT.
Patient problems: Insufficient Information
MAUDE report 18375890 ↗InjuryNov 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 27, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 18, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; 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 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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