DJO SURGICAL 428-01-090Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888912081375), received between Apr 12, 2016 and Dec 23, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 23, 2019Unstable; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY - HIP WAS UNSTABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9511006 ↗
• InjuryApr 12, 2016Insufficient Device Problem Information

  REVISION SURGERY - DUE TO THE PATIENT HAVING AN INFECTION; THE SURGEON REPLACED THE ORIGINAL PROXIMAL BOXY.

  Patient problems: Unspecified Infection

  MAUDE report 5572014 ↗

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