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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

All Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer devices →

Sources and updates

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