DJO SURGICAL 341-12-703Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 3L 12MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888912166904), received between Mar 12, 2019 and Jul 27, 2022 — classified as 4 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 18, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available3
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Pain2
- Fall1
- Joint Dislocation1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT FELL POST OPERATION AND ANTERIORLY DISLOCATED. NEEDED TO REVISE TO CONSTRAINED POLY AND REVISION FEMUR.
Patient problems: Fall; Joint Dislocation
MAUDE report 15117256 ↗InjuryOct 21, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT WAS EXPERIENCING PAIN AND SIGNIFICANT INSTABILITY.
Patient problems: Pain
MAUDE report 12678264 ↗InjuryMay 14, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO DRAINING INCISION AND PAIN. SURGEON SWAPPED OUT THE POLY INSERT.
Patient problems: Pain
MAUDE report 11829538 ↗InjuryMar 12, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO AN INFECTION RESULTING IN A POLY SWAP.
Patient problems: Unspecified Infection
MAUDE report 8414744 ↗
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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