Omnifit 6070-0730ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327023480), received between Aug 7, 2019 and Nov 30, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

1 other recall cover devices cleared under the same FDA submission (K031744); 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 30, 2020Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO LOOSENING. THEY WERE REVISED FROM A HEMI HIP TO HEMI HIP. A OMNIFIT STEM, C-TAPER HEAD, AND UHR BIPOLAR HEAD SYSTEM WERE REVISED TO MODULAR HIP SYSTEM WITH NO ALLEGATIONS AGAINST THE REVISED HEAD AND SYSTEM. PRIMARY IMPLANTATION WAS DONE APPROXIMATELY 13 YEARS AGO. REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10919809 ↗
• MalfunctionAug 7, 2019Difficult to Insert; Difficult to Insert

  AS REPORTED: "SURGEON WAS PERFORMING A BIPOLAR HIP PROCEDURE¿.STEM WAS IMPLANTED¿HE ATTEMPTED TO PUT THE HEAD ON THE TRUNNION AND IT WOULD NOT LOCK ON¿..A SECOND HEAD WAS OPENED AND IT ALSO WOULD NOT LOCK¿.HE REMOVED THE STEM AND IMPLANTED A SECOND #7 HFX STEM¿.HE THEN PUT THE HEAD ON TO THE TRUNNION, IT LOCKED WITHOUT INCIDENT, HE ADDED THE BIPOLAR HEAD, AND REDUCED THE HIP". A SURGICAL DELAY OF 10 MINUTES WAS REPORTED. UPDATE (B)(6) 2019 WG: SPOKE TO REP. RIGHT HIP. THE FIRST ATTEMPTED FEMORAL HEAD WAS ULTIMATELY IMPLANTED IN THE PATIENT. THE SECOND HEAD WAS WASTED AND WILL BE RETURNED. REP WAS NOT PRESENT FOR THE PROCEDURE. REP WILL PROVIDE THE USAGE SHEET, BUT DOES NOT HAVE ACCESS TO ANY ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8869725 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031744. One submission often covers many models, so check the product and lot details in each record.

• Z-0896-2009 · Nov 13, 2008 · Terminated
  Omnifit HFX 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