Omnifit 6017-0625ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327038248), received between Sep 23, 2018 and Sep 23, 2018 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K913812, K982032); 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 16, 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.

• InjurySep 23, 2018Degraded; Material Deformation; Degraded; Material Deformation

  IT WAS REPORTED THAT:"IT WAS REPORTED THROUGH THE ATTORNEY FOR THE PATIENT, AS A RESULT OF A LAWSUIT, THAT ALLEGEDLY THE PATIENT RECEIVED A TRIDENT CERAMIC ON CERAMIC HIP SYSTEM. IT WAS FURTHER ALLEGED THAT, THE PATIENT BEGAN TO EXPERIENCE SOME DIFFICULTIES, REQUIRING A REVISION SURGERY ON (B)(6) 2008." UPDATE AS PER MEDICAL REVIEW: "ON (B)(6) 2008 A REVISION OF THE RIGHT TOTAL HIP WAS PERFORMED WITH REMOVAL OF LOOSE, FRACTURED CERAMIC PIECES. EXTENSIVE METALLOSIS WAS NOTED AND A REVISION TOTAL HIP WAS PERFORMED FOR A DIAGNOSIS OF FRACTURED CERAMIC HEAD AND LINER, DISPLACED METAL LINER, EROSION SUPERIOR ACETABULAR SHELL, AND EXTENSIVE WEAR DEBRIS."

  Patient problems: Erosion; Inflammation; Injury; Reaction

  MAUDE report 7900659 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K913812, K982032. One submission often covers many models, so check the product and lot details in each record.

• Z-0891-2009 · Nov 13, 2008 · Terminated
  Omnifit HA Hip Stem These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or