DJO SURGICAL 341-12-706Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 6L 12MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This DJO Surgical knee guide is used during knee procedures. The reports mostly describe knee looseness or instability and infections, often followed by revision surgery. There are 41 adverse event reports naming its identifier, including 41 injuries and no deaths. 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
- 39
- Deaths reported
- 0
- Injuries reported
- 39
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00888912166935), received between Jun 7, 2017 and Apr 6, 2026 — classified as 39 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 Problem21
- Appropriate Device Problem Term/Code Not Available10
- Unstable5
- Insufficient Device Problem Information4
- Device Dislodged or Dislocated1
- Improper or Incorrect Procedure or Method1
- Loose or Intermittent Connection1
Patient problems
- Unspecified Infection14
- Joint Laxity10
- Fall4
- Insufficient Information4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Implant Pain2
- Rupture2
- No Code Available1
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
InjuryApr 6, 2026Adverse Event Without Identified Device or Use Problem
InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem
PATIENTS KNEE WAS FEELING LOOSE. DOCTOR SWAPPED OUT THE 6X12 POLY TO A THICKER 6X16 POLY AND CONDUCTED A WASHOUT. SURGERY WAS COMPLETED AS INTENDED.
Patient problems: Joint Laxity
MAUDE report 24772464 ↗InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem
InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO MILD INFECTION
Patient problems: Unspecified Infection
MAUDE report 24554007 ↗InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT PRESENTED TO CLINIC WITH INFECTED KNEE.
Patient problems: Unspecified Infection
MAUDE report 23653490 ↗InjurySep 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY DUE TO FLEXION CONTRACTURE ISSUES.
Patient problems: Insufficient Information
MAUDE report 23100885 ↗InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DOCTOR PERFORMED A POLY SWAP TO INCREASE SIZE OF POLYREASON UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 22503276 ↗InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 20, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryOct 15, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 23, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJan 8, 2024Adverse 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
InjurySep 19, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT HAD LIGAMENTOUS LAXITY, NEEDED TO UPSIZE POLY INSERT.
Patient problems: Joint Laxity
MAUDE report 17357320 ↗InjuryAug 12, 2022Unstable
REVISION SURGERY - DUE TO INSTABILITY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15218487 ↗InjuryAug 10, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY. ORIGINAL IMPLANTS WERE A SIZE 6 LEFT FEMUR AND TIBIA, 29 PATELLA, AND A SIZE 6X12 INSERT. PATIENT UNDERWENT REVISION SURGERY FOR A RUPTURED PATELLA TENDON SUSTAINED. AN ALLOGRAFT ACHILLES TENDON WAS USED FOR THE REPAIR. THE SURGEON FELT LIKE THE REVISION WAS A GOOD OPPORTUNITY TO REPLACE THE INSERT, HOWEVER, THE PATIENT'S KNEE WAS UNSTABLE WHICH MAY HAVE BEEN FROM A FALL AND INJURY. A SIZE 6X 19 INSERT WAS SUCCESSFULLY IMPLANTED.
Patient problems: Rupture
MAUDE report 15202759 ↗InjuryJun 10, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INSTABILITY.
Patient problems: Insufficient Information
MAUDE report 14658675 ↗InjuryFeb 8, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - THE PATIENT FELL AND HAD A PATELLAR TENDON AVULSION. SURGEON REPAIRED THE PATELLAR TENDON WITH AN ALLOGRAFT AND WENT TO A THINNER POLY.
Patient problems: Fall
MAUDE report 13479954 ↗InjuryJul 14, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO ITEM WAS A SIZE BIGGER.
Patient problems: Insufficient Information
MAUDE report 12170160 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page