DJO SURGICAL 315-0B-712Recalls & reported problems
Encore Medical, L.P. · INSERT, REVISION EXPRT, SZ B X 12MM, E-PLUS · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888912113991), received between Jan 24, 2018 and May 15, 2025 — classified as 9 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 Available2
- Unstable2
- Contamination1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Unspecified Infection5
- Joint Laxity2
- No Code Available2
- Insufficient Information1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryMay 15, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO RESURFACING.
Patient problems: Insufficient Information
MAUDE report 16735225 ↗InjuryNov 7, 2021Loosening of Implant Not Related to Bone-Ingrowth
REVISION SURGERY : PATIENT KNEE WAS LOOSE, POLY WAS IMPLANTED.
Patient problems: Joint Laxity
MAUDE report 12762196 ↗InjuryOct 12, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT FIGHTING INFECTION, REPLACED POLY WHILE OPEN.
Patient problems: Unspecified Infection
MAUDE report 12618973 ↗InjuryApr 22, 2021Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - PATIENT SUFFERED FROM REPEATED INFECTIONS. SURGEON ULTIMATELY DECIDED TO REMOVE ALL IMPLANTS AND TREAT THE JOINT WITH ANTIBIOTICS.
Patient problems: Unspecified Infection
MAUDE report 11711524 ↗InjuryDec 19, 2018Unstable
REVISION SURGERY - THE POLY INSERT WAS CHANGED TO THICKER INSERT FOR STABILITY, 10-19MM.
Patient problems: No Code Available
MAUDE report 8180703 ↗InjuryJan 24, 2018Contamination
REVISION SURGERY - DUE TO THE PATIENT DEVELOPING AN INFECTION.
Patient problems: No Code Available; Unspecified Infection
MAUDE report 7216857 ↗
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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