DJO SURGICAL 342-12-710Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 10R 12MM, VE · Class 1
Data updated Oct 16, 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 00888912167475), received between Mar 16, 2017 and May 21, 2026 — classified as 22 injuries.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem14
- Appropriate Device Problem Term/Code Not Available6
- Loose or Intermittent Connection1
- Material Too Rigid or Stiff1
- Unstable1
Patient problems
- Unspecified Infection12
- Joint Laxity4
- No Code Available2
- Failure of Implant1
- Implant Pain1
- Insufficient Information1
- Medical device site infection1
- Pain1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem
InjurySep 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; 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
InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 12, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryOct 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 27, 2022Adverse 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 16052253 ↗InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT WAS HAVING INSTABILITY IN BOTH FLEXION AND EXTENSION. SURGEON INCREASED THE THICKNESS OF THE POLY FOR MORE STABILITY.
Patient problems: Joint Laxity
MAUDE report 15626668 ↗InjuryJun 24, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAD A DEBRIDEMENT FOR INFECTION.
Patient problems: Unspecified Infection
MAUDE report 14809590 ↗InjuryJun 24, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 14809523 ↗InjurySep 21, 2021Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - POLYETHYLENE INSERT WAS SWAPPED OUT DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 12505699 ↗InjuryNov 4, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO POLY EXCHANGE.
Patient problems: Insufficient Information
MAUDE report 10784314 ↗InjuryJul 8, 2020Material Too Rigid or Stiff
REVISION SURGERY - DUE TO STIFF AND CATCHING.
Patient problems: No Code Available
MAUDE report 10244593 ↗InjuryApr 3, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAD INFECTION.
Patient problems: Unspecified Infection
MAUDE report 9921014 ↗InjuryMar 27, 2020Appropriate Device Problem Term/Code Not Available
InjuryJan 30, 2019Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO THE RIGHT KNEE NOT ABLE TO REACH FULL EXTENSION WITH A 12 MILLIMETER INSERT, SO THE POLY NEEDED TO BE REPLACED WITH A THINNER ONE.
Patient problems: No Code Available
MAUDE report 8290233 ↗InjuryApr 18, 2018Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO THE PATIENT GETTING AN INFECTION. THE PATIENT CAME BACK FOR A WASHOUT AND INSERT EXCHANGE.
Patient problems: Unspecified Infection
MAUDE report 7440547 ↗InjuryMar 16, 2017Loose or Intermittent Connection
REVISION SURGERY - THE PATIENT HAD A BILATERAL TOTAL KNEE ARTHROPLASTY (TKA) IN 2016, THEY DEVELOPED PAIN AND LAXITY IN THEIR JOINT. THE SURGEON PERFORMED A SYNOVECTOMY WITH POLY EXCHANGE TO STABILIZE KNEE.
Patient problems: Failure of Implant; Pain
MAUDE report 6411009 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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