DJO SURGICAL 315-0B-719Recalls & reported problems
Encore Medical, L.P. · INSERT, REVISION EXPRT, SZ B X 19.5MM, E-PLUS · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888912114028), received between Dec 3, 2016 and Dec 30, 2025 — classified as 10 injuries.
The most frequently reported specific device problem is “Unstable” (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
- Adverse Event Without Identified Device or Use Problem4
- Appropriate Device Problem Term/Code Not Available4
- Unstable2
- Insufficient Device Problem Information1
Patient problems
- Unspecified Infection7
- Insufficient Information1
- No Code Available1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - SCAR REVISION WITH POLY SWAP, UNKNOWN REASON FOR POLY SWAP.
Patient problems: Insufficient Information
MAUDE report 23927520 ↗InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjurySep 3, 2020Unstable
InjuryJun 23, 2020Unstable; Appropriate Device Problem Term/Code Not Available
SECOND REVISION SURGERY - DUE TO INSTABILITY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10184986 ↗InjuryMay 15, 2020Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO POSSIBLE INFECTION, REMOVED POLY AND DID A THOROUGH WASHOUT.
Patient problems: Unspecified Infection
MAUDE report 10061700 ↗InjuryOct 23, 2019Appropriate Device Problem Term/Code Not Available
InjuryDec 27, 2017Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO A POSSIBLE INFECTION.
Patient problems: Unspecified Infection
MAUDE report 7148512 ↗InjuryDec 3, 2016Insufficient Device Problem Information
REVISION SURGERY - DUE TO AN INFECTION AND AN IRRIGATION AND DRAINAGE (I&D) PROCEDURE.
Patient problems: Unspecified Infection
MAUDE report 6143800 ↗
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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