DJO SURGICAL 360-13-508Recalls & reported problems
Encore Medical, L.P. · INSERT, POSTERIOR STABILIZED, SERIES 500, SIZE8 13MM CM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888912116428), received between Apr 14, 2016 and Nov 14, 2022 — classified as 5 injuries.
The most frequently reported specific device problem is “Break” (1 report).
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Break1
- Device Slipped1
- Unstable1
Patient problems
- Failure of Implant1
- Joint Laxity1
- No Code Available1
- No Known Impact Or Consequence To Patient1
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - POST WAS SHEARED OFF OF THE PS POLYETHYLENE INSERT, CAUSING CLUNKING. THE DAMAGED POLY INSERT WAS REMOVED AND REPLACED WITH A NEW PS POLY INSERT.
Patient problems: Joint Laxity
MAUDE report 15793209 ↗InjurySep 23, 2020Unstable
SECOND REVISION SURGERY - DUE TO UNSTABLE.
Patient problems: Failure of Implant
MAUDE report 10574478 ↗InjuryApr 11, 2019Device Slipped
REVISION SURGERY - DUE TO THE SCREW BACKING OUT OF THE INSERT. THE SURGEON REMOVED AND REPLACED INSERT WITH A DJO PRODUCT. THE SCREW AND PATELLA WERE REMOVED AND REPLACED BY ANOTHER VENDOR.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8504757 ↗InjurySep 26, 2016Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - THE KNEE WAS INFECTED BECAUSE OF THE SKIN; SO THE SURGEON REPLACED THE POLY.
Patient problems: Unspecified Infection
MAUDE report 5976616 ↗InjuryApr 14, 2016Break
REVISION SURGERY - DUE TO THE POST BREAKING.
Patient problems: No Code Available
MAUDE report 5579207 ↗
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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