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DJO SURGICAL 341-14-710Recalls & reported problems

Encore Medical, L.P. · EMPOWR 3D KNEETM INS, 10L 14MM, VE · Class 1

Data updated Oct 16, 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 00888912167079), received between Oct 23, 2020 and Jul 14, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Unstable” (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 16, 2026.

Reports received per month

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 1 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem8
  • Appropriate Device Problem Term/Code Not Available1
  • Unstable1

Patient problems

  • Joint Laxity4
  • Unspecified Infection3
  • Injury1
  • Insufficient Information1

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 14, 2026Adverse Event Without Identified Device or Use Problem

    REVISION SURGERY DUE TO INFECTION.

    Patient problems: Unspecified Infection

    MAUDE report 25819849 ↗
  • InjuryJul 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REVISION SURGERY - DUE TO INFECTION.

    Patient problems: Unspecified Infection

    MAUDE report 19697912 ↗
  • InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REVISION SURGERY - DUE TO LOOSENING.

    Patient problems: Joint Laxity

    MAUDE report 19218435 ↗
  • InjuryJan 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REVISION SURGERY - DUE TO INFECTION.

    Patient problems: Unspecified Infection

    MAUDE report 18515207 ↗
  • InjuryNov 13, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

    REVISION SURGERY - DUE TO INSTABILITY.

    Patient problems: Joint Laxity

    MAUDE report 18127949 ↗
  • InjuryAug 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REVISION SURGERY - THE PATIENT'S PATELLA WASN'T TRACKING ON THE FEMUR.

    Patient problems: Joint Laxity

    MAUDE report 17476771 ↗
  • InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REVISION SURGERY - DUE TO UNKNOWN REASON.

    Patient problems: Insufficient Information

    MAUDE report 17047594 ↗
  • InjuryDec 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    REVISION SURGERY - DUE TO INSTABILITY.

    Patient problems: Joint Laxity

    MAUDE report 16073878 ↗
  • InjuryOct 23, 2020Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY - THE PATIENT SUSTAINED AN INJURY REOPENING THE WOUND FROM REMOVE KNEE REPLACEMENT. SURGERY JUST 10 DAYS PRIOR. BECAUSE THE INJURY EXPOSED THE IMPLANTS, UNDERWENT A WASHOUT SURGERY AND HAD REMOVE POLY INSERT REPLACED.

    Patient problems: Injury

    MAUDE report 10726620 ↗

Other Guide, Surgical, Instrument devices

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Sources and updates

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