DJO SURGICAL 428-16-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888912081467), received between Sep 20, 2017 and Sep 22, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K092331); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2021Break

  REVISION SURGERY: LIMA HIP STEM ALLEGEDLY FAILED.

  Patient problems: Failure of Implant

  MAUDE report 12514965 ↗
• InjuryJul 24, 2018Loose or Intermittent Connection

  SECOND REVISION SURGERY - DUE TO THE STEM BEING LOOSE. THE SURGEON REMOVED AND REPLACED THE STEM, HEAD, AND SLEEVE.

  Patient problems: No Information

  MAUDE report 7715151 ↗
• InjurySep 20, 2017Loose or Intermittent Connection; Device Operates Differently Than Expected

  REVISION SURGERY - THE IMPLANT WAS LOOSE AND WAS NOT GROWING INTO THE FEMORAL CANAL, THE SURGEON WENT IN AN REPLACED THE STEM WITH A LAGER ONE.

  Patient problems: No Code Available

  MAUDE report 6881201 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092331. One submission often covers many models, so check the product and lot details in each record.

• Z-1191-2017 · Jan 10, 2017 · Terminated
  LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Modular Revision Femoral hip stem is made up of a modular stem coupled with a proper neck by means of a Mors