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DJO SURGICAL 360-15-506Recalls & reported problems

Encore Medical, L.P. · INSERT, POSTERIOR STABILIZED, SERIES 500, SIZE6 15MM CM · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
6
Deaths reported
0
Injuries reported
6
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888912116480), received between Dec 21, 2015 and Dec 23, 2021 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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

  • Appropriate Device Problem Term/Code Not Available3
  • Device Dislodged or Dislocated1
  • Loose or Intermittent Connection1
  • Naturally Worn1
  • Noise, Audible1

Patient problems

  • Unspecified Infection3
  • Failure of Implant1
  • Joint Laxity1
  • No Code Available1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 23, 2021Noise, Audible

    REVISION SURGERY - PATIENT PRESENTED WITH POSTERIOR SUBLUXATION AND KNEE HAD A GRINDING NOISE DURING FLEXION. THE POST ON THE PS POLY HAD SNAPPED OFF AND HAD TO BE REPLACED. A SIZE 19MM WAS ALSO IMPLANTED INSTEAD OF A 15MM TO ACHIEVE GREATER STABILITY.

    Patient problems: Joint Laxity

    MAUDE report 13079041 ↗
  • InjuryMay 23, 2019Appropriate Device Problem Term/Code Not Available

    THIRD REVISION SURGERY - DUE TO AN INFECTED TOTAL KNEE. IRRIGATION AND DEBRIDEMENT (I&D) POLY SWAP WAS PERFORMED.

    Patient problems: Unspecified Infection

    MAUDE report 8639009 ↗
  • InjuryMar 29, 2019Appropriate Device Problem Term/Code Not Available

    SECOND REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION.

    Patient problems: Unspecified Infection

    MAUDE report 8464161 ↗
  • InjuryMar 12, 2019Appropriate Device Problem Term/Code Not Available

    REVISION SURGERY - DUE TO AN INFECTION AND POLY SWAP.

    Patient problems: Unspecified Infection

    MAUDE report 8413494 ↗
  • InjuryFeb 28, 2017Loose or Intermittent Connection; Naturally Worn

    REVISION SURGERY - DUE TO EXCESSIVE POLY WEAR LEADING TO LOOSE KNEE.

    Patient problems: Failure of Implant

    MAUDE report 6366219 ↗
  • InjuryDec 21, 2015Device Dislodged or Dislocated

    REVISION SURGERY - DUE TO THE PATIENT DISLOCATING; THE SURGEON REPLACED BOTH WITH 360-19-506. THE SURGEON WASTED ONE OF THE NEW IMPLANTS; ONLY ONE KNEE WAS REVISED.

    Patient problems: No Code Available

    MAUDE report 5315363 ↗

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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