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
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 · TerminatedExprt 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
- iTotal® PS TPS111111102Conformis, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive327 reports
- ATTUNE 1506-00-006Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive287 reports
- ATTUNE 1506-00-008Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive233 reports
- iTotal® Cruciate Retaining (CR) Knee Replacement System TCR121111102Conformis, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive150 reports
- ATTUNE 1506-70-007Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 recall2 deaths74 reports
- ATTUNE 1516-40-506Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive121 reports
- ATTUNE 1506-70-006Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 recall70 reports
- ATTUNE 1516-40-605Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive120 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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