DJO SURGICAL 360-13-506Recalls & reported problems
Encore Medical, L.P. · INSERT, POSTERIOR STABILIZED, SERIES 500, SIZE6 13MM 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 00888912116411), received between Dec 16, 2015 and Jun 9, 2021 — classified as 7 injuries.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break2
- Unstable2
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
- Loose or Intermittent Connection1
- Naturally Worn1
Patient problems
- Loss of Range of Motion2
- No Code Available2
- Pain2
- Failure of Implant1
- No Known Impact Or Consequence To Patient1
- Unspecified Infection1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryJun 9, 2021Break; Unstable
REVISION SURGERY - IT WAS REPORTED THE BEST BEFORE DATE WAS UNTIL JUNE 2018. NOW THE MOVEMENT WAS NO LONGER FLUID, BUT RATHER CHOPPY. DURING AN INSPECTION, IT WAS NOTICED THAT THE PEG OF THE PE SLIDING SURFACE WAS BROKEN. PER BFARM CASE NUMBER: (B)(4), PATIENT REPORTED A SUDDEN INCREASING FEELING OF INSTABILITY OF THE KNEE JOINT AFTER STANDING UP.
Patient problems: Failure of Implant
MAUDE report 11967542 ↗InjuryNov 13, 2020Naturally Worn
REVISION SURGERY - DUE TO WORN TIBIAL INSERT.
Patient problems: No Code Available
MAUDE report 10838723 ↗InjuryJun 22, 2018Loose or Intermittent Connection
REVISION SURGERY - DUE TO THE POLY BECOMING LOOSE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7630151 ↗InjurySep 27, 2017Break
REVISION SURGERY - DUE TO THE POST ON TIBIAL POLY INSERT BREAKING; SURGERY WAS REQUIRED TO RESTORE THE PATIENT'S KNEE STABILITY.
Patient problems: No Code Available
MAUDE report 6898877 ↗InjuryApr 11, 2017Adverse Event Without Identified Device or Use Problem
REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 6481380 ↗InjuryMar 7, 2017Insufficient Device Problem Information
REVISION SURGERY - DUE TO LOSS OF MOTION AND PAIN.
Patient problems: Loss of Range of Motion; Pain
MAUDE report 6385791 ↗InjuryDec 16, 2015Unstable
REVISION SURGERY - DUE TO INSTABILITY, PAIN AND LOSS OF MOTION.
Patient problems: Loss of Range of Motion; Pain
MAUDE report 5304229 ↗
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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