DJO SURGICAL 428-00-090Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888912081269), received between Dec 22, 2016 and Dec 22, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 2016Break

  REVISION SURGERY - DUE TO THE PREVIOUS STEM BREAKING OUT OF THE POSTERIOR CORTEX POST OPERATION.

  Patient problems: No Code Available

  MAUDE report 6201457 ↗

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