DJO SURGICAL 315-0C-717Recalls & reported problems
Encore Medical, L.P. · INSERT, REVISION EXPRT, SZ C X 17MM, E-PLUS · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888912114103), received between Jan 19, 2018 and Sep 25, 2026 — classified as 15 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 Available7
- Adverse Event Without Identified Device or Use Problem5
- Insufficient Device Problem Information2
- No Apparent Adverse Event1
- Unstable1
Patient problems
- Unspecified Infection7
- Insufficient Information4
- Joint Laxity1
- No Code Available1
- Pain1
- Post Operative Wound Infection1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2026No Apparent Adverse Event
Patient problems: Insufficient Information
MAUDE report 50905484 ↗InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - NEEDED A THICKER INSERT. UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 24437622 ↗InjuryFeb 4, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryOct 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJul 5, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INSTABILITY SO THE SURGEON REPLACED TIBIAL INSERT WITH A THICKER POLY.
Patient problems: Insufficient Information
MAUDE report 14921098 ↗InjuryJun 21, 2022Appropriate Device Problem Term/Code Not Available
InjuryMay 25, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT HAD INSTABILITY AND PAIN. SURGEON REVISED TO A THICKER POLY INSERT.
Patient problems: Pain
MAUDE report 14498077 ↗InjuryFeb 25, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - SURGEON DID AN IRRIGATION AND DRAINAGE AND SWAPPED THE POLY AS WELL.
Patient problems: Insufficient Information
MAUDE report 11379925 ↗InjuryDec 3, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT ACQUIRED A POST OPERATION INFECTION. SURGEON SWAPPED THE POLY.
Patient problems: Unspecified Infection
MAUDE report 10943173 ↗InjurySep 9, 2020Insufficient Device Problem Information
InjuryAug 10, 2020Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO INFECTION AND THE POLY WAS SWAPPED.
Patient problems: Unspecified Infection
MAUDE report 10384676 ↗InjuryApr 8, 2020Appropriate Device Problem Term/Code Not Available
InjuryAug 2, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT ACQUIRED A POST OPERATION INFECTION. SURGEON PERFORMED A WASH OUT AND CHANGE THE POLY.
Patient problems: Post Operative Wound Infection
MAUDE report 8856084 ↗InjuryMay 10, 2019Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT BEING PRESENTED WITH AN INFECTED TOTAL KNEE.
Patient problems: Unspecified Infection
MAUDE report 8601033 ↗InjuryJan 19, 2018Insufficient Device Problem Information
REVISION SURGERY - DUE TO THE PATIENT DEVELOPING AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 7205388 ↗
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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