DJO SURGICAL 360-11-508Recalls & reported problems
Encore Medical, L.P. · INSERT, POSTERIOR STABILIZED, SERIES 500, SIZE8 11MM CM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888912116350), received between Sep 3, 2015 and Feb 18, 2026 — classified as 7 injuries.
The most frequently reported specific device problem is “Unstable” (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
- Adverse Event Without Identified Device or Use Problem3
- Unstable2
- Device Dislodged or Dislocated1
- Insufficient Device Problem Information1
Patient problems
- No Code Available2
- Unspecified Infection2
- Discomfort1
- Joint Dislocation1
- Joint Laxity1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryFeb 18, 2026Device Dislodged or Dislocated
InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
InjuryDec 7, 2017Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT HAVING ANTERIOR KNEE DISCOMFORT.
Patient problems: Discomfort
MAUDE report 7095748 ↗InjuryJun 1, 2017Unstable
REVISION SURGERY - DUE TO INSTABILITY THE SURGEON SWAPPED OUT THE POLY FOR A THICKER POSTERIOR STABILIZED (PS) CONSTRAINED POLY.
Patient problems: No Code Available
MAUDE report 6605982 ↗InjuryJan 5, 2017Unstable
REVISION SURGERY - DUE TO THE PATIENT EXPERIENCING INSTABILITY AND AN INFECTION. THE SURGEON PERFORMED A WASH OUT AND POLY SWAP.
Patient problems: Unspecified Infection
MAUDE report 6226514 ↗InjurySep 3, 2015Insufficient Device Problem Information
REVISION SURGERY: DUE TO THE PATIENT BEING VERY TIGHT IN FLEXION. THE SURGEON REMOVED AN 11MM INSERT AND WENT DOWN TO A 9MM INSERT. HE PERFORMED A PARTIAL RELEASE AND REMOVED SCAR TISSUE FROM THE KNEE JOINT.
Patient problems: No Code Available
MAUDE report 5054183 ↗
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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