DJO SURGICAL 341-14-706Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 6L 14MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00888912167031), received between Aug 31, 2017 and Feb 25, 2026 — classified as 22 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 Problem12
- Unstable5
- Appropriate Device Problem Term/Code Not Available4
- Improper or Incorrect Procedure or Method1
- Loose or Intermittent Connection1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Material Rupture1
Patient problems
- Unspecified Infection7
- Joint Laxity5
- Fall4
- No Code Available2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Bone Fracture(s)1
- Damage to Ligament(s)1
- Limb Fracture1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
InjuryFeb 25, 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
InjuryOct 21, 2025Unstable; Unstable
IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY.
Patient problems: Joint Laxity
MAUDE report 23347023 ↗InjuryMay 20, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT FELL POST SURGERY AND RUPTURED THEIR PATELLA TENDON. THE SURGEON REPLACED THE POLY INSERT WHILE HE WAS REPAIRING THE PATELLA TENDON.
Patient problems: Fall
MAUDE report 21289255 ↗InjuryJul 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO FRACTURE.
Patient problems: Bone Fracture(s); Limb Fracture
MAUDE report 19736595 ↗InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Medical device site infection
MAUDE report 18213151 ↗InjuryNov 14, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMar 23, 2022Unstable
InjuryJan 11, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT FELL AND LANDED ON LEFT KNEE STATUS POST LEFT TOTAL KNEE REPLACEMENT. TIBIA COMPONENT BECAME LOOSE.
Patient problems: Fall
MAUDE report 13231743 ↗InjuryDec 22, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INFECTION. WASHED OUT JOINT AND REPLACED INSERT.
Patient problems: Unspecified Infection
MAUDE report 13060325 ↗InjuryAug 5, 2021Adverse Event Without Identified Device or Use Problem
InjuryJun 15, 2021Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - POLY SWAP FOR LOOSENING OR LAXITY. NO KNOWN INFECTION OR TRAUMA.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12005610 ↗InjuryNov 23, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT COMPLAINED OF MOTION ISSUES.
Patient problems: Loss of Range of Motion
MAUDE report 10884846 ↗InjuryJun 7, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT HAVING FALLEN. THE SURGEON THOUGHT THAT THE PATELLA WAS RUPTURED BUT IT WAS NOT, BUT HE DID CHANGE THE INSERT.
Patient problems: Fall
MAUDE report 8680804 ↗InjuryAug 15, 2018Improper or Incorrect Procedure or Method
REVISION SURGERY - DUE TO THE PATIENT FALLING WHILE USING THE RESTROOM AND HEARING A POP. THE SURGEON REPAIRED A TORN MEDIAL COLLATERAL LIGAMENT (MCL) AND A 14 MILLIMETER POLY WAS REMOVED AND REPLACED WITH A 19MILLIMETER POLY.
Patient problems: Damage to Ligament(s); Fall
MAUDE report 7786477 ↗InjuryNov 22, 2017Unstable
REVISION SURGERY - DUE TO THE PATIENT HAVING INSTABILITY.
Patient problems: No Code Available
MAUDE report 7053829 ↗InjuryAug 31, 2017Material Rupture
REVISION SURGERY - DUE TO THE PATIENT HAVING A QUAD TENDON RUPTURE. THE SURGEON SWAPPED THE POLY AND INCREASED THE THICKNESS DURING REPAIR.
Patient problems: No Code Available
MAUDE report 6836181 ↗
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