Secur-Fit 6054-0812SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327020823), received between Feb 22, 2017 and Jan 20, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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.

• InjuryJan 20, 2020Migration; Migration

  UPDATE AS PER ATTACHED OPERATIVE NOTE: SUBSIDENCE OF FEMORAL STEM, RIGHT. SUBSIDENCE OF IMPLANTS.

  Patient problems: Injury

  MAUDE report 9608377 ↗
• InjuryFeb 22, 2017Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S THIGH WAS PAINFUL, SURGERY TO REPLACE WITH LARGER STEM AND SHORTER HEAD AND LINER.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 6350174 ↗

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-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
• 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