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DJO SURGICAL 315-0C-714Recalls & reported problems

Encore Medical, L.P. · INSERT, REVISION EXPRT, SZ C X 14.5MM, E-PLUS · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
7
Deaths reported
0
Injuries reported
7
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888912114097), received between Dec 12, 2017 and Sep 30, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K140830); they may or may not involve this specific model.

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

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

Most reported problems

Device problems

  • Appropriate Device Problem Term/Code Not Available3
  • Insufficient Device Problem Information2
  • Adverse Event Without Identified Device or Use Problem1
  • Unstable1

Patient problems

  • Unspecified Infection5
  • Joint Laxity1
  • No Code Available1
  • Pain1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • InjurySep 30, 2026Unstable

    Patient problems: Joint Laxity

    MAUDE report 50941450 ↗
  • InjuryMay 27, 2021Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY - PATIENT PRESENTED AT THE SURGEON OFFICE WITH A PAINFUL KNEE. SAMPLES WERE DRAWN AND AN INFECTION WAS DETECTED. REVISION SURGERY WAS REQUIRED WITH A WASH OUT AND POLY SWAP.

    Patient problems: Pain; Unspecified Infection

    MAUDE report 11898097 ↗
  • InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem

    REVISION SURGERY - PATIENT DEVELOPED AN INFECTION IN THE JOINT AND SURGEON WASH OUT THE JOINT AND REPLACED THE INSERT.

    Patient problems: Unspecified Infection

    MAUDE report 11006497 ↗
  • InjuryNov 13, 2020Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY - PATIENT ACQUIRED A POST OPERATION INFECTION. IRRIGATION AND DRAINAGE AND CHANGE THE POLY.

    Patient problems: Unspecified Infection

    MAUDE report 10836318 ↗
  • InjuryJun 21, 2019Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY -THE PATIENT WAS INFECTED.

    Patient problems: Unspecified Infection

    MAUDE report 8722012 ↗
  • InjuryFeb 20, 2018Insufficient Device Problem Information

    REVISION SURGERY - DUE TO IRRIGATION OF KNEE.

    Patient problems: No Code Available

    MAUDE report 7284086 ↗
  • InjuryDec 12, 2017Insufficient Device Problem Information

    REVISION SURGERY - DUE TO THE PATIENT ACQUIRING A POST OPERATION INFECTION. THE SURGEON WASHED HIP OUT AND SWAPPED OUT THE POLY.

    Patient problems: Unspecified Infection

    MAUDE report 7110673 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140830. One submission often covers many models, so check the product and lot details in each record.

  • Z-0165-2016 · Sep 16, 2015 · Terminated
    Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.

Other Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive devices

All Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive devices →

Sources and updates

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