DJO SURGICAL 342-16-706Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 6R 16MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888912167635), received between Oct 1, 2016 and Sep 25, 2026 — classified as 12 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem8
- Appropriate Device Problem Term/Code Not Available3
- Insufficient Device Problem Information1
Patient problems
- Unspecified Infection6
- Joint Laxity3
- Insufficient Information2
- Pain1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50892495 ↗InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryFeb 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - REQUIRED INTERVENTION TO PREVENT IMPAIRMENT/DAMAGE
Patient problems: Insufficient Information
MAUDE report 16315174 ↗InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryNov 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryMay 11, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INSTABILITY.
Patient problems: Insufficient Information
MAUDE report 14364667 ↗InjuryNov 20, 2019Adverse Event Without Identified Device or Use Problem
InjuryJul 11, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT ACQUIRED A POST-OP INFECTION. SURGEON PERFORMED A WASH OUT AND WENT UP ONE SIZE ON THE POLY.
Patient problems: Unspecified Infection
MAUDE report 8783129 ↗InjuryJul 1, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY; DUE TO THE PATIENT HAVING PAIN; THE SURGEON REVISED THINKING IT WAS AN OSTEOPHYTE AND REPLACED THE POLY.
Patient problems: Pain
MAUDE report 8751069 ↗InjuryOct 1, 2016Insufficient Device Problem Information
REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 5992729 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page