DJO SURGICAL 400-01-297Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888912075749), received between May 16, 2017 and Mar 31, 2021 — classified as 3 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

Recent adverse event reports

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

• InjuryMar 31, 2021Material Integrity Problem

  REVISION SURGERY - KERAMOS CERAMIC-ON-CERAMIC BEARING IMPLANTED. REVISED FOR PAIN AND SUSPECTED CERAMIC LINER FAILURE. DURING REVISION SURGERY, NO LINER WAS EVIDENT AND EXTENSIVE METALLOSIS WAS NOTED. CUP WAS REMOVED AND REPLACED WITH COMPETITIVE 60MM CUP AND LINER. DJO 36MM DELTA OPTION HEAD AND 7.0MM ADAPTIVE SLEEVE WERE UTILIZED TO REPLACE THE HEAD.

  Patient problems: Failure of Implant; Metal Related Pathology; Pain

  MAUDE report 11596353 ↗
• InjuryFeb 2, 2018Device Dislodged or Dislocated

  REVISION SURGERY - DUE TO THE PATIENT DISLOCATING. ADDITIONAL INFORMATION WAS RECEIVED ON 02 FEB 2018, PER THE AGENT, THE SURGEON DID NOT REMOVE THE SHELL OR THE STEM. WHAT HE DID REMOVE WAS THE LINER AND THE HEAD. HE REPLACED THE LINER WITH A COMPETITOR'S CEMENTED LINER AND PUT A DJO 36 HEAD IN.

  Patient problems: Joint Dislocation

  MAUDE report 7237525 ↗
• InjuryMay 16, 2017Break

  REVISION SURGERY - DUE TO THE LINEAR BREAKING.

  Patient problems: Failure of Implant

  MAUDE report 6570638 ↗