DJO SURGICAL 341-16-705Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 5L 16MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888912167123), received between Nov 10, 2017 and Mar 30, 2026 — classified as 9 injuries.
The most frequently reported specific device problem is “Unstable” (3 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 Problem5
- Unstable3
- Appropriate Device Problem Term/Code Not Available2
- Loose or Intermittent Connection1
Patient problems
- Joint Laxity4
- Unspecified Infection3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Code Available1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryMar 30, 2026Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMar 17, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 1, 2022Adverse Event Without Identified Device or Use Problem
InjuryOct 26, 2021Appropriate Device Problem Term/Code Not Available
THIRD REVISION SURGERY - PATIENT WAS INFECTED. REMOVED SIZE 5X16 EMPOWER REPLACED WITH 5X19.
Patient problems: Unspecified Infection
MAUDE report 12699252 ↗InjuryJul 6, 2021Appropriate Device Problem Term/Code Not Available
InjuryDec 18, 2020Unstable
REVISION SURGERY - THE PATIENT FELT UNSTABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11037287 ↗InjuryNov 10, 2017Loose or Intermittent Connection
REVISION SURGERY - DUE TO THE PATIENT HAVING LAXITY IN THE KNEE. THE SURGEON INCREASED BEARING THICKNESS.
Patient problems: No Code Available
MAUDE report 7022425 ↗
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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