Secur-Fit 6051-0830SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327021028), received between Oct 4, 2019 and Sep 21, 2020 — classified as 2 injuries.

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

2 other recalls cover devices cleared under the same FDA submission (K041170, K051738); 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.

• InjurySep 21, 2020Fracture; Fracture

  IT WAS REPORTED THE PATIENT'S LEFT HIP WAS REVISED 1 DAY POST-IMPLANT DUE TO A FEMORAL PERIPROSTHETIC FRACTURE SUFFERED IN A FALL AT THE HOSPITAL. A SECUR-FIT MAX STEM AND BIOLOX HEAD WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, ANOTHER BIOLOX HEAD, AND 3 CABLE AND SLEEVE SETS. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD, PROVIDED PRIMARY AND REVISION USAGE SHEETS, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Bone Fracture(s)

  MAUDE report 10559145 ↗
• InjuryOct 4, 2019Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LFIT ANATOMIC COCR V40 FEMORAL HEAD ON HIS RIGHT HIP ON OR ABOUT (B)(6) 2012. IT IS FURTHER ALLEGED THAT HE SUFFERED INJURIES AS A RESULT OF IMPLANTATION OF THE DEVICE AT ISSUE, DEVICE RECALL AND EXCESSIVE LEVELS OF CHROMIUM AND COBALT IN HIS BLOOD. PATIENT HAS NOT YET SCHEDULED A SURGERY FOR EXPLANTATION OF THE FEMORAL HEAD AT ISSUE.

  Patient problems: Inflammation; Metal Related Pathology; Reaction

  MAUDE report 9156023 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041170, K051738. One submission often covers many models, so check the product and lot details in each record.

• Z-0893-2009 · Nov 13, 2008 · Terminated
  Secur-Fit Max 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
• Z-0894-2009 · Nov 13, 2008 · Terminated
  Primary Secur-fit Plus Max Hip Stem These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular componen