DJO SURGICAL 341-12-707Recalls & reported problems
Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 7L 12MM, VE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a surgical guide/instrument from Encore Medical used during knee replacement surgery. The 46 reports mostly describe revision surgery — the knee implant being replaced because of infection, loosening, or instability — with one report describing a broken fragment of the plastic insert left in the patient. All46 reports involved injuries and no deaths. No recalls name this device, and the report count is about the same as the previous 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 45
- Deaths reported
- 0
- Injuries reported
- 45
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00888912166942), received between Jun 9, 2017 and Aug 5, 2026 — classified as 45 injuries.
The most frequently reported specific device problem is “Unstable” (8 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 Problem27
- Appropriate Device Problem Term/Code Not Available13
- Unstable8
- Loose or Intermittent Connection2
- Patient Device Interaction Problem1
Patient problems
- Unspecified Infection19
- Joint Laxity12
- Insufficient Information4
- Fall2
- No Code Available2
- No Known Impact Or Consequence To Patient2
- Pain2
- Complaint, Ill-Defined1
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Fall
MAUDE report 50145003 ↗InjuryJul 14, 2026Adverse Event Without Identified Device or Use Problem
InjuryMay 27, 2026Unstable
InjuryMar 13, 2026Patient Device Interaction Problem
REVISION SURGERY - POLY SWAP FOR 3D TOTAL KNEE. PATIENT WAS TIGHT. CLEANED OUT AND SAME SIZE POLY PLACED BACK IN BROKEN FRAGMENTED PIECE LEFT IN THE PATIENT.
Patient problems: Foreign Body In Patient; Loss of Range of Motion
MAUDE report 24596606 ↗InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem
InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO POLY EXCHANGE, UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 22891760 ↗InjuryMar 18, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJan 30, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryDec 6, 2024Unstable; Unstable
InjuryNov 27, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryOct 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 23, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - KNEE WAS SEEMINGLY UNSTABLE.
Patient problems: Joint Laxity
MAUDE report 18218192 ↗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
InjuryJun 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT WAS COMPLAINING ABOUT A LITTLE BIT OF PAIN AND INSTABILITY. SURGEON INCREASED THE THICKNESS OF THE POLY.
Patient problems: Joint Laxity; Pain
MAUDE report 15917529 ↗InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO AN INFECTION. PERFORMED AN IRRIGATION AND DRAINAGE.
Patient problems: Medical device site infection
MAUDE report 15510510 ↗InjuryJun 3, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY PATIENT EXPERIENCED LAXITY IN KNEE AND SURGEON INCREASED POLY THICKNESS TO RESTORE PROPER TIGHTNESS.
Patient problems: Insufficient Information
MAUDE report 14598602 ↗InjuryMar 24, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - POSSIBLE INFECTION, JOINT WAS WASHED OUT AND NEW POLY IMPLANTED.
Patient problems: Unspecified Infection
MAUDE report 13876590 ↗InjuryFeb 16, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY: PATIENT NEEDED A PATELLA. SURGEON CHANGED ALL THE INSERT.
Patient problems: Insufficient Information
MAUDE report 13542100 ↗
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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