DJO SURGICAL 400-05-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888912076302), received between Jan 4, 2022 and Jul 20, 2023 — classified as 2 injuries.

1 other recall cover devices cleared under the same FDA submission (K082844); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 17357314 ↗
• InjuryJan 4, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - THE HIP JOINT WAS INFECTED.

  Patient problems: Unspecified Infection

  MAUDE report 13161173 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082844. One submission often covers many models, so check the product and lot details in each record.

• Z-2604-2023 · Aug 4, 2023 · Open, Classified
  DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443