DJO SURGICAL 315-0A-712Recalls & reported problems
Encore Medical, L.P. · INSERT, REVISION EXPRT, SZ A X 12MM, E-PLUS · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888912113908), received between Jan 6, 2017 and Jun 9, 2026 — classified as 8 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 Problem5
- Appropriate Device Problem Term/Code Not Available2
- Unstable2
Patient problems
- Joint Laxity4
- Unspecified Infection4
- Insufficient Information1
- Muscle/Tendon Damage1
- Rupture1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryJun 9, 2026Unstable
POLY SWAP TO THICKER INSERT DUE TO HYPEREXTENSION.
Patient problems: Joint Laxity
MAUDE report 25445759 ↗InjuryFeb 20, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryJun 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PATIENT FELL ON BLEACHERS AT SOCCER GAME AND CUT KNEE. KNEE THEN BECAME INFECTED. WASH OUT WITH POLY SWAP TO RID INFECTION.
Patient problems: Joint Laxity; Muscle/Tendon Damage; Unspecified Infection
MAUDE report 19442311 ↗InjuryNov 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE PATIENT HAD BECOME UNSTABLE OVER TINE FOLLOWING A REVISION KNEE ARTHROPLASTY AND NEEDED A THICKER ARTICULAR SURFACE.
Patient problems: Joint Laxity
MAUDE report 15853815 ↗InjuryAug 2, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - POST OPERATION INFECTION, RUPTURED PATELLA TENDON.
Patient problems: Rupture; Unspecified Infection
MAUDE report 15153829 ↗InjuryMar 31, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO INSTABILITY.
Patient problems: Insufficient Information
MAUDE report 13969302 ↗InjuryNov 15, 2017Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT HAVING ACQUIRED A POST OPERATION INFECTION. THE SURGEON PERFORMED AN IRRIGATION & DRAINAGE AND SWAPPED OUT THE SAME SIZE POLY.
Patient problems: Unspecified Infection
MAUDE report 7033474 ↗InjuryJan 6, 2017Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION; THEY DID A WASH OUT AND REPLACED THE INSERT WITH A NEW ONE, SAME SIZE.
Patient problems: Unspecified Infection
MAUDE report 6230792 ↗
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/Metal/Polymer devices
- ATTUNE 1506-00-005Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER589 reports
- ATTUNE 1506-00-004Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER580 reports
- JOURNEY 74012812Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER502 reports
- JOURNEY 74011856Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER438 reports
- PERSONA™ 42-5099-094-00Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER406 reports
- JOURNEY 74011857Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER388 reports
- ATTUNE 1506-00-007Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER288 reports
- ATTUNE 1506-00-003Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER271 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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