DJO SURGICAL 341-14-707Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 7L 14MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00888912167048), received between Nov 14, 2017 and Aug 19, 2026 — classified as 18 injuries.
The most frequently reported specific device problem is “Unstable” (10 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
- Unstable10
- Adverse Event Without Identified Device or Use Problem8
- Appropriate Device Problem Term/Code Not Available5
- Inadequacy of Device Shape and/or Size1
- Loose or Intermittent Connection1
- No Apparent Adverse Event1
Patient problems
- Joint Laxity6
- Insufficient Information4
- Pain2
- Unspecified Infection2
- Fall1
- Limb Fracture1
- No Code Available1
- No Information1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
InjuryAug 19, 2026No Apparent Adverse Event
Revision surgery - Due to unknown revision reason / Poly swap.
Patient problems: Insufficient Information
MAUDE report 50312424 ↗InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem
InjuryMar 20, 2026Unstable
InjuryOct 23, 2025Inadequacy of Device Shape and/or Size; Unstable; Inadequacy of Device Shape and/or Size; Unstable
IT WAS REPORTED THAT THE PATIENT REQUIRED REVISION SURGERY DUE TO INSTABILITY, SURGEON WENT UP IN SIZE BY 2MM.
Patient problems: Joint Laxity
MAUDE report 23366097 ↗InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 24, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO UNKNOWN REVISION REASON.
Patient problems: Insufficient Information
MAUDE report 21146045 ↗InjuryApr 16, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryApr 14, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO FRACTURE AND INSTABILITY.
Patient problems: Joint Laxity; Limb Fracture
MAUDE report 19103065 ↗InjuryJun 9, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMar 15, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO TIBIA COMPONENT LOOSENING.
Patient problems: Insufficient Information
MAUDE report 13775074 ↗InjuryDec 21, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT COMPLAINS OF RIGHT KNEE PAIN S/P LEFT TOTAL KNEE.
Patient problems: Pain
MAUDE report 13052670 ↗InjuryAug 18, 2021Unstable
REVISION SURGERY - DUE TO INSTABILITY.
Patient problems: Insufficient Information
MAUDE report 12338589 ↗InjuryJul 6, 2021Appropriate Device Problem Term/Code Not Available
InjuryJan 13, 2021Unstable
REVISION SURGERY - PATIENT PRESENTED WITH PAIN AND INSTABILITY. SURGEON FELT THICKER INSERT WAS NEEDED.
Patient problems: Pain
MAUDE report 11163281 ↗InjuryJul 13, 2020Unstable; Appropriate Device Problem Term/Code Not Available
THIRD REVISION SURGERY - PATIENT WAS UNSTABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10264296 ↗InjuryJul 3, 2019Unstable; Appropriate Device Problem Term/Code Not Available
InjuryNov 14, 2017Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE SURGEON RESURFACED A PATELLA THAT HAD NOT PREVIOUSLY BEEN RESURFACED. WHILE THERE, THE SURGEON CHANGED THE INSERT. THERE WAS NOT ANY CONCERN FOR THE SURGEON. HE WAS PLEASED WITH THE SURGERY.
Patient problems: No Code Available
MAUDE report 7027871 ↗
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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