Secur-Fit 6052-1035SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327021134), received between Jun 13, 2017 and Mar 16, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED: "PATIENT HAD A PROXIMAL FEMUR FRACTURE SO WAS REVISED. ALL COMPONENTS WERE EXPLANTED. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY." THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD OR ENDO HEAD.

  Patient problems: Bone Fracture(s)

  MAUDE report 16551293 ↗
• InjuryJan 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO FEMORAL PERIPROSTHETIC FRACTURE. A SECUR-FIT MAX STEM, UNITRAX HEAD, AND SLEEVE WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH ANOTHER UNITRAX HEAD AND SLEEVE, AND A CABLE AND SLEEVE SET. REP PROVIDED PRIMARY AND REVISION USAGE SHEETS. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED IMPLANTS, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 13362084 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION USAGE SHEET THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. A 36 + 5MM BIOLOX HEAD AND #10 SECUR-FIT STEM WERE EXPLANTED. SPOKE TO REP: THE FRACTURE OCCURRED ON THE FEMUR BONE, ABOUT HALF WAY UP THE LENGTH OF THE STEM, BUT THE STEM WAS NOT FRACTURED. THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Hip Fracture

  MAUDE report 12211670 ↗
• InjuryJul 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A POLY INSERT AND A C-TAPER FEMORAL HEAD "WERE EXPLANTED DURING A RIGHT HIP REVISION DUE TO ALTR." REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 10269987 ↗
• InjuryJun 13, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  COMPANY REPRESENTATIVE REPORTED A RIGHT HIP REVISION DUE TO PAIN. UPDATE: 05/23/2017 - COMPANY REPRESENTATIVE REPORTED THAT THE SURGEON MENTIONED THAT THERE MAY HAVE BEEN A PERI PROSTHETIC FRACTURE.

  Patient problems: Bone Fracture(s); Injury; Pain

  MAUDE report 6638959 ↗

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