DJO SURGICAL 341-14-708Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 8L 14MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00888912167055), received between Jun 8, 2017 and Aug 17, 2026 — classified as 22 injuries.
The most frequently reported specific device problem is “Unstable” (4 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Aug 12, 2022Class IIOpen, Classified
Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery.
Z-0126-2023 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem10
- Appropriate Device Problem Term/Code Not Available7
- Unstable4
- Loosening of Implant Not Related to Bone-Ingrowth2
- Loose or Intermittent Connection1
- Packaging Problem1
Patient problems
- Unspecified Infection11
- Joint Laxity5
- Insufficient Information4
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem
InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem
InjuryAug 5, 2026Unstable
InjuryJul 17, 2026Adverse Event Without Identified Device or Use Problem
InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem
InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem
InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth
InjuryNov 7, 2025Unstable; Unstable
InjuryApr 22, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT'S KNEE WAS UNSTABLE. REVISED TO A LARGER POLY.
Patient problems: Joint Laxity
MAUDE report 15421120 ↗InjuryJun 21, 2022Packaging Problem
COMPLIANT - DUE TO WRONG IMPLANT INSIDE OF BOX. UPON OPENING BOX FOR A "L" SIZE 8, 14MM KNEE INSERT, WE DISCOVERED A HIP POLY LINER INSIDE. SLIGHTLY - HAD TO RETRIEVE 2ND INSERT.
Patient problems: Insufficient Information
MAUDE report 14758088 ↗InjuryJun 3, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY DUE TO INFECTION, SURGEON WASHOUT AND INSERT EXCHANGE.
Patient problems: Unspecified Infection
MAUDE report 14598610 ↗InjuryMar 4, 2022Appropriate Device Problem Term/Code Not Available
InjuryFeb 11, 2022Unstable; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY PATIENT NEEDED A THICKER LINER FOR STABILITY.
Patient problems: Insufficient Information
MAUDE report 13514934 ↗InjuryFeb 2, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT WAS TIGHT IN JOINT, SO THE SURGEON DID A LINER SWAP.
Patient problems: Insufficient Information
MAUDE report 13426070 ↗InjuryMay 26, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO POLY EXCHANGE, WASH OUT.
Patient problems: Insufficient Information
MAUDE report 11882817 ↗InjuryFeb 2, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO PATIENT PRESENTED WITH POSSIBLE JOINT INFECTION. PHYSICIAN OPTED TO EXCHANGE POLY INSERT DURING THE PROCEDURE. NO OTHER IMPLANTS EXCHANGED.
Patient problems: Unspecified Infection
MAUDE report 11267439 ↗InjuryJul 2, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - SURGEON PERFORMED INCISION & DRAINAGE DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10224688 ↗InjuryJan 2, 2020Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY - DUE TO THE PATIENT STILL COMPLAINING OF LAXITY AFTER PRIOR REVISION.
Patient problems: No Code Available
MAUDE report 9540491 ↗InjuryJun 8, 2017Loose or Intermittent Connection
REVISION SURGERY - DUE TO THE PATIENT REPORTING INSTABILITY. THE PATIENT WAS IN A CAR WRECK AND THIS CAUSED LOOSENING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6621607 ↗
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 341-10-711Encore Medical, L.P. · Guide, Surgical, Instrument1 recall16 reports
- DJO SURGICAL 342-14-705Encore Medical, L.P. · Guide, Surgical, Instrument1 recall14 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 · each recall links to the FDA recall notice
- 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