DJO SURGICAL 400-03-444Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888912076227), received between May 8, 2021 and Aug 13, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

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

• InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO PATIENT FELL, BROKE HER HIP.

  Patient problems: Insufficient Information

  MAUDE report 19978338 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - PATIENT DEVELOPED A BAD INFECTION. A TWO STAGE REVISION REQUIRED. USED EVOLVE, FEMORAL HEAD, AND EMPOWR LINER AS MOLDS FOR THE PLACEMENT OF A SPACER WITH PERFORMED.

  Patient problems: Medical device site infection

  MAUDE report 18229384 ↗
• InjuryApr 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY - DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 16758596 ↗
• InjuryJun 9, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY: PATIENT HAD ORIGINAL PRIMARY TOTAL HIPS SURGERY. PATIENT DEVELOPED AN INFECTION AND REQUIRED AN ONE STAGE HIP EXCHANGE WITH ANTIBIOTIC WASH OUT.

  Patient problems: Unspecified Infection

  MAUDE report 14645959 ↗
• InjuryNov 11, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - JOINT WAS LOOSE AND WAS DISLOCATING.

  Patient problems: Joint Dislocation

  MAUDE report 12798745 ↗
• InjuryMay 8, 2021Appropriate Device Problem Term/Code Not Available

  SECOND REVISION SURGERY - AFTER A REVISION SURGERY OF THE TOTAL HIP ARTHROPLASTY. THE SURGEON BROUGHT THE PATIENT BACK TO ADD NECK LENGTH AND CREATE MORE STABILITY IN THE JOINT BY SWAPPING A +8.0MM HEAD WITH A 10.5MM HEAD.

  Patient problems: Insufficient Information

  MAUDE report 11795254 ↗

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