DJO SURGICAL 360-09-504Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888912116251), received between Jan 18, 2017 and Mar 18, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Unstable” (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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 21638654 ↗
• InjuryApr 20, 2021Break; Unstable

  REVISION SURGERY - DUE TO PATIENT HAD INSTABILITY IN RIGHT KNEE. NOTICED THE POST OF THE POLY WAS BROKEN. REMOVED AND REPLACED THE INSERT.

  Patient problems: Insufficient Information

  MAUDE report 11697587 ↗
• InjuryApr 13, 2018Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - DUE TO THE PATIENT BEING PRESENTED WITH BILATERAL KNEE PAIN. IT WAS DETERMINED THAT THE PATIENT HAD AN INFECTION. THE SURGEON DECIDED TO PERFORM A BILATERAL WASH OUT AND POLY EXCHANGE. THE PATIENT HAD BILATERAL TOTAL KNEES DONE IN 2010. PATIENT'S RIGHT KNEE WAS REVISED IN 2013. LEFT SIDE WAS UNTOUCHED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 7430806 ↗
• InjuryJan 18, 2017Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO A SCAR RESECTION SURGERY; SAME POLY USED IN REVISION. SCAR RESECTION DUE TO LACK OF PHYSICAL THERAPY.

  Patient problems: No Code Available

  MAUDE report 6260473 ↗