DJO SURGICAL 360-15-504Recalls & reported problems
Encore Medical, L.P. · INSERT, POSTERIOR STABILIZED, SERIES 500, SIZE4 15MM CM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888912116473), received between Feb 20, 2017 and Nov 3, 2025 — classified as 6 injuries.
The most frequently reported specific device problem is “Naturally Worn” (2 reports).
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
- Naturally Worn2
- Unstable2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Detachment Of Device Component1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information3
- Joint Laxity1
- No Code Available1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryNov 3, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjurySep 7, 2021Naturally Worn
REVISION SURGERY - DUE TO WORN POLY.
Patient problems: Insufficient Information
MAUDE report 12432828 ↗InjuryAug 26, 2021Naturally Worn
REVISION SURGERY - DUE TO POLY WEAR.
Patient problems: Insufficient Information
MAUDE report 12370084 ↗InjurySep 9, 2020Unstable
SECOND REVISION SURGERY - DUE TO INSTABILITY.
Patient problems: Insufficient Information
MAUDE report 10511146 ↗InjuryApr 11, 2018Insufficient Device Problem Information
REVISION SURGERY - DUE TO THE PATIENT BEING PRESENTED WITH BILATERAL KNEE PAIN. IT WAS DETERMINED THAT THE PATIENT HAD AN INFECTION. THE SURGEON DECIDED TO PERFORM A BILATERAL WASH OUT AND POLY EXCHANGE. THE PATIENT HAD BILATERAL TOTAL KNEES DONE IN 2010. PATIENT'S RIGHT KNEE WAS REVISED IN 2013. LEFT SIDE WAS UNTOUCHED.
Patient problems: Pain; Unspecified Infection
MAUDE report 7421606 ↗InjuryFeb 20, 2017Break; Detachment Of Device Component
REVISION SURGERY - DUE TO THE ORIGINAL POLY BREAKING LOOSE FROM THE SCREW. THE POLY POPPED OFF THE BASEPLATE, BUT THE SCREW IS STIL INTACT WITHIN THE TIBIAL BASEPLATE.
Patient problems: No Code Available
MAUDE report 6343217 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page