DJO SURGICAL 428-00-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888912081245), received between Jan 13, 2017 and Jan 13, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 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.

• InjuryJan 13, 2017Loose or Intermittent Connection; Device Dislodged or Dislocated

  REVISION SURGERY - DUE TO THE PROXIMAL BODY NOT BEING FULLY SEATED AND ENGAGED FROM FIRST THE SURGERY. PROXIMAL BODY EVENTUALLY CAME DISASSOCIATED FROM THE STEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6250779 ↗

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