DJO SURGICAL 341-12-704Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 4L 12MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888912166911), received between Jan 8, 2018 and Aug 18, 2026 — classified as 15 injuries.
The most frequently reported specific device problem is “Unstable” (4 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 Problem9
- Unstable4
- Loose or Intermittent Connection2
- Appropriate Device Problem Term/Code Not Available1
- No Apparent Adverse Event1
Patient problems
- Joint Laxity6
- Unspecified Infection4
- Insufficient Information2
- Loss of Range of Motion1
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
InjuryAug 18, 2026No Apparent Adverse Event
Revision surgery - Due to Unknown Revision reason / Poly swap.
Patient problems: Insufficient Information
MAUDE report 50291507 ↗InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem
PATIENT HAD HER KNEE REPLACED ROUGHLY SIX MONTHS AGO AND CAN'T REACH TERMINAL FLEXION, SO DOCTOR DID A SCAR EXCISION AND POLY EXCHANGE.
Patient problems: Loss of Range of Motion
MAUDE report 24879884 ↗InjuryJan 7, 2026Unstable
InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - POLY SWAP, UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 23012366 ↗InjuryDec 13, 2024Unstable; Unstable
REVISION SURGERY DUE TO LOOSENING AND INSTABILITY.
Patient problems: Joint Laxity
MAUDE report 20931988 ↗InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 8, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 11, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 27, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: PATIENT SHOWED SIGNS OF INFECTION. SURGEON TOOK PREVIOUS COPIOUSLY & PUT A NEW LINER IN SAME SIZE ARMS THICKNESS.
Patient problems: Unspecified Infection
MAUDE report 13372119 ↗InjuryMar 11, 2021Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - INFECTION. SWAPPED OUT THE OLD TIBIAL INSERT WITH A NEW TIBIAL INSERT.
Patient problems: Unspecified Infection
MAUDE report 11461791 ↗InjuryAug 27, 2019Loose or Intermittent Connection
REVISION SURGERY - THE PATIENT WAS LOOSE IN FLEXION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8937561 ↗InjuryJan 8, 2018Loose or Intermittent Connection
REVISION SURGERY - DUE TO THE PATIENT'S KNEE BEING LOOSE.
Patient problems: No Code Available
MAUDE report 7173397 ↗
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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