Omnifit 6097-0835Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327022391), received between Feb 7, 2019 and Nov 26, 2019 — classified as 1 injury, 1 malfunction.

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

2 other recalls cover devices cleared under the same FDA submission (K983226); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2019Osseointegration Problem; Osseointegration Problem

  AS REPORTED: "RIGHT REVISION THA. DIAGNOSIS: FAILED RIGHT TOTAL HIP. NO FURTHER INFORMATION AVAILABLE PER HOSPITAL." REP HAS PROVIDED AN X-RAY AND EXPLANT PICTURES. UPDATE 31/OCTOBER/2019: SPOKE TO REP. PATIENT WAS REVISED DUE TO STEM LOOSENING. THE STEM, HEAD, LINER, AND DALL-MILES CABLE WERE REVISED. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE HEAD AND LINER. NO ALLEGATIONS AGAINST THE DALL- MILES CABLE WERE REPORTED TO THE REP. AFTER IMPLANTING A CONSTRAINED LINER, THE SURGEON DECIDED HE WANTED TO GO WITH A NON- CONSTRAINED LINER INSTEAD (NO ALLEGATIONS AGAINST THE CONSTRAINED LINER). WHEN TRYING TO EXPLANT THE CONSTRAINED LINER, THE SHELL BECAME DISLODGED INTRA-OPERATIVELY AND WAS REVISED (NO PRIOR ALLEGATIONS TO THE SHELL OR PLAN TO REVISE IT). PATIENT'S BONE QUALITY IS UNKNOWN. PATIENT WAS REVISED TO A CEMENTED EXETER STEM, TRIDENT II SHELL, POLY LINER AND 36 -5 METAL HEAD.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9378383 ↗
• MalfunctionFeb 7, 2019Packaging Problem; Packaging Problem

  PRIMARY PROCEDURE, LEFT HIP. IT WAS REPORTED THAT AFTER REMOVING THE OUTER STERILE BLISTER FROM THE PRISTINE OUTER BOX, THE TYVEK COVERING WAS OBSERVED TO HAVE HOLES. THE OUTER BLISTER WAS OPENED AND HOLES WERE ALSO OBSERVED ON THE TYVEK OF THE INNER STERILE BLISTER. DUE TO STERILITY CONCERNS, THE DEVICE WAS NOT USED. SURGEON DECIDED TO IMPLANT A SIZE 7 STEM INSTEAD OF THE ORIGINAL SIZE 8 AS THE DEVICE WAS READILY AVAILABLE IN THE O.R. REP REPORTED THAT THERE WAS NO SURGICAL DELAY. THE DEVICE AND STERILE BLISTERS ARE AVAILABLE FOR RETURN, BUT THE HOSPITAL DISPOSED OF THE OUTER BOX. THE IMPLANT WAS NOT LISTED ON THE IMPLANT SHEET AS A WASTED/ IN AND OUT DEVICE. REP WAS PRESENT FOR THE PROCEDURE AND WITNESSED THE EVENT. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION WILL NOT BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8319107 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K983226. One submission often covers many models, so check the product and lot details in each record.

• Z-0899-2009 · Nov 13, 2008 · Terminated
  Omnifit Eon 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 revisio
• Z-0898-2009 · Nov 13, 2008 · Terminated
  Omnifit FC Cemented 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 prima