DJO SURGICAL 360-11-504Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888912116336), received between Jan 4, 2016 and Jul 12, 2017 — classified as 3 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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 12, 2017Break; Device Dislodged or Dislocated

  REVISION SURGERY - DUE TO THE POSTERIOR STABILIZED (PS) POST BREAKING; IT DISLODGED FROM THE BASEPLATE.

  Patient problems: No Code Available

  MAUDE report 6705993 ↗
• InjuryJul 7, 2017Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO THE PATIENT BECOMING UNSTABLE.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 6694962 ↗
• InjuryJan 4, 2016Break

  SECOND REVISION SURGERY - THE PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY DONE ON (B)(6) 2000 WHERE SHE RECEIVED AN ENCORE FOUNDATION TOTAL KNEE. ON (B)(6) 2006 SHE UNDERWENT A TIBIAL POLY EXCHANGE DUE TO THE POST BEING BROKEN ON THE INSERT. SHE IS BACK AGAIN WITH THE SAME SYMPTOMS. DUE TO THE POST BEING BROKEN ON THE 4X11 SERIES 500 P.S. TIBIAL INSERT THAT WAS PLACED IN 2006. THE SURGEON CLEANED OUT ALL THE LOOSE PIECES, AS WELL AS THE REMAINING INSERT, AND REVISED HER WITH A NEW 4X13 SERIES 500 P.S TIBIAL INSERT. THE PATIENT SHOWED GOOD STABILITY; THE SURGEON WAS SATISFIED AND CLOSED THE PATIENT.

  Patient problems: No Information

  MAUDE report 5341771 ↗