DJO SURGICAL 342-12-707Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 7R 12MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Encore Medical surgical guide is used during knee replacement surgery to position the implant. The 49 reports mostly describe patients later needing a second operation, with reasons including infection, loosening of the implant, ongoing knee pain, and instability of the joint; there were no deaths, and 49 injuries. No recalls name 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
- 48
- Deaths reported
- 0
- Injuries reported
- 48
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00888912167444), received between Dec 20, 2017 and Sep 28, 2026 — classified as 48 injuries.
The most frequently reported specific device problem is “Unstable” (9 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 Problem31
- Appropriate Device Problem Term/Code Not Available10
- Unstable9
- Improper or Incorrect Procedure or Method1
- Inadequacy of Device Shape and/or Size1
- Loose or Intermittent Connection1
- No Apparent Adverse Event1
- Patient Device Interaction Problem1
Patient problems
- Unspecified Infection18
- Joint Laxity11
- Insufficient Information6
- Fall3
- Loss of Range of Motion3
- Pain2
- Discomfort1
- Implant Pain1
Recent adverse event reports
The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Patient Device Interaction Problem
Patient problems: Loss of Range of Motion
MAUDE report 50926089 ↗InjuryJun 30, 2026No Apparent Adverse Event
REVISION SURGERY - REMOVED 12 POLY AND IMPLANTED A 16, UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 25673183 ↗InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem
InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem
InjuryMay 8, 2026Unstable
InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem
InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem
InjuryDec 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 3, 2025Unstable; Unstable
InjuryAug 25, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryAug 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 20, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMar 19, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMar 17, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INSERT TOO TIGHT.
Patient problems: Loss of Range of Motion
MAUDE report 21044892 ↗InjuryNov 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PAIN AND INFECTION.
Patient problems: Unspecified Infection
MAUDE report 19564306 ↗InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT FELL RESULTING IN HER SURGERY INCISION RE-OPENING AND THE BEGINNING SIGNS OF INFECTION. THIS DROVE DR. DECISION TO SWAP THE INSERT WITH A NEW ONE.
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 18754782 ↗InjuryJan 30, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO KNEE SUBLUXING.
Patient problems: Insufficient Information
MAUDE report 17794998 ↗
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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