DJO SURGICAL 315-0C-719Recalls & reported problems
Encore Medical, L.P. · INSERT, REVISION EXPRT, SZ C 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 00888912114110), received between Nov 10, 2017 and Dec 3, 2025 — classified as 10 injuries.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).
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
- Loose or Intermittent Connection1
- Material Rupture1
- Microbial Contamination of Device1
- Unstable1
Patient problems
- Unspecified Infection5
- Insufficient Information2
- Joint Laxity1
- Medical device site infection1
- No Code Available1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryOct 30, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryAug 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - PATIENT HAD A REVISION TOTAL KNEE ARTHOPLASTY DONE DUE TO AN INFECTION.
Patient problems: Medical device site infection
MAUDE report 15303690 ↗InjuryMay 9, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - LINER EXCHANGE FOR INFECTION.
Patient problems: Unspecified Infection
MAUDE report 14337936 ↗InjuryNov 7, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - SURGEON WANTED A THICKER TIBIA INSERT TO ADDRESS INSTABILITY.
Patient problems: Insufficient Information
MAUDE report 12759133 ↗InjuryNov 1, 2021Material Rupture; Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT RUPTURED HIS EXTENSOR MECHANISM. SURGEON SWAPPED POLY DURING PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 12733958 ↗InjuryNov 20, 2019Microbial Contamination of Device
REVISION SURGERY - SURGEON PERFORMED A WASHOUT AND POLY SWAP DUE TO PATIENT ACQUIRING A POST-OP INFECTION.
Patient problems: Unspecified Infection
MAUDE report 9349526 ↗InjurySep 12, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY PATIENT ACQUIRED A POST OPERATIVE INFECTION. SURGEON PERFORMED A WASH OUT AND SWAPPED THE POLY.
Patient problems: Unspecified Infection
MAUDE report 9010284 ↗InjuryNov 10, 2017Loose or Intermittent Connection
REVISION SURGERY - DUE TO THE PATIENT BEING LOOSE IN FLEXION AND EXTENSION. THE SURGEON WANTED TO PUT IN THICKER POLY BUT THE PATIENT ALREADY HAD A 19.5 IN. THE SURGEON PULLED EVERYTHING AND STARTED OVER, USING AUGMENTS TO MAKE UP SPACE.
Patient problems: No Code Available
MAUDE report 7022306 ↗
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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