DJO SURGICAL 341-19-710Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 10L 19MM, VE · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888912167277), received between Jan 4, 2022 and Oct 16, 2024 — classified as 3 injuries.
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 Problem2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Bacterial Infection1
- Hemorrhage/Blood Loss/Bleeding1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 4, 2022Adverse Event Without Identified Device or Use Problem
REVISION SURGERY DUE TO INFECTION OR WASHOUT, POLY TIBIAL REPLACEMENT.
Patient problems: Bacterial Infection
MAUDE report 13456484 ↗InjuryJan 4, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT PRESENTED WITH EXCESS BLOOD DRAINAGE FOLLOWING A LEFT TOTAL KNEE ARTHROPLASTY. SURGEON REOPENED THE WOUND IN AN ATTEMPT TO COAGULATE THE BLEEDERS WITH HIS KNEE. DURING THE PROCEDURE SURGEON REMOVED THE POLY INVENTORIED ABOVE AND REPLACED WITH 3D POLY PERIOD AT END OF STATEMENT.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 13161495 ↗
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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