DJO SURGICAL 360-11-506Recalls & reported problems
Encore Medical, L.P. · INSERT, POSTERIOR STABILIZED, SERIES 500, SIZE6 11MM CM · Class 2 · Implant
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 00888912116343), received between Feb 22, 2017 and Mar 26, 2025 — classified as 10 injuries.
The most frequently reported specific device problem is “Unstable” (5 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
- Unstable5
- Appropriate Device Problem Term/Code Not Available4
- Adverse Event Without Identified Device or Use Problem3
- Break1
- Detachment of Device or Device Component1
Patient problems
- Joint Laxity3
- No Code Available2
- Pain2
- Bone Fracture(s)1
- Failure of Implant1
- Implant Pain1
- No Known Impact Or Consequence To Patient1
- Sepsis1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryMar 26, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY: DUE TO DISSOCIATION, INSTABILITY AND LOOSENING.
Patient problems: Joint Laxity
MAUDE report 21699495 ↗InjuryFeb 27, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
InjuryOct 4, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO PAIN AND INSTABILITY.
Patient problems: Implant Pain; Joint Laxity
MAUDE report 17873971 ↗InjuryMay 7, 2022Appropriate Device Problem Term/Code Not Available
REVISION SURGERY PATIENT WAS SEPTIC WITH INFECTION NOT DUE TO THE PRODUCT. SURGEON CHOSE TO CLEAN THE JOINT AND SWAP THE POLY DURING THE PROCEDURE.
Patient problems: Sepsis; Unspecified Infection
MAUDE report 14317681 ↗InjuryNov 11, 2021Appropriate Device Problem Term/Code Not Available
InjurySep 18, 2019Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - SURGEON WANTED TO CHANGE THE POLY INSERT TO A CONSTRAINED INSERT TO HELP STABILITY IN THE PATIENTS KNEE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9085008 ↗InjuryJun 4, 2019Unstable
InjuryMay 30, 2018Appropriate Device Problem Term/Code Not Available
REVISION SURGERY - DUE TO A FRACTURED POLY POST.
Patient problems: Bone Fracture(s)
MAUDE report 7553024 ↗InjuryJul 14, 2017Break
REVISION SURGERY - DUE TO THE POSTERIOR STABILIZED (PS) INSERT BREAKING DURING NORMAL WALKING.
Patient problems: Failure of Implant; No Code Available
MAUDE report 6714905 ↗InjuryFeb 22, 2017Unstable; Detachment of Device or Device Component
REVISION SURGERY - DUE TO THE PATIENT PRESENTING WITH INSTABILITY AND PAIN TEN YEARS POST-OPERATION. THE POSTERIOR STABILIZED (PS) POST WAS SHEARED OFF.
Patient problems: Pain
MAUDE report 6350822 ↗
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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