DJO SURGICAL 342-16-709Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 9R 16MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888912167666), received between Aug 11, 2021 and Oct 10, 2024 — classified as 7 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.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available4
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Unspecified Infection6
- Medical device site infection1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 14, 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 15792594 ↗InjuryDec 21, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT PRESENTED WITH POSSIBLY INFECTION. POLY SWAP DURING IRRIGATION & DRAINAGE OF THE JOINT.
Patient problems: Unspecified Infection
MAUDE report 13052686 ↗InjuryDec 21, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT PRESENTED WITH POSSIBLY INFECTION. POLY SWAP DURING IRRIGATION AND DRAINAGE OF THE JOINT.
Patient problems: Unspecified Infection
MAUDE report 13052678 ↗InjuryOct 4, 2021Appropriate Device Problem Term/Code Not Available
InjuryAug 11, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO POLY SWAP, PATIENT WAS INFECTED.
Patient problems: Unspecified Infection
MAUDE report 12308007 ↗
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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