Secur-Fit 6051-0935SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327021035), received between Mar 27, 2018 and Jun 16, 2023 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO PAIN AND SUSPECTED STEM LOOSENING (LOOSENING WAS NEITHER CONFIRMED NOR DENIED BY THE SURGEON INTRA-OPERATIVELY). A STEM, HEAD, AND LINER WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT, FEMORAL HEAD, ADM/ MDM POLY INSERT, AND MDM METAL LINER.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 17141499 ↗
• InjuryJan 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT 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. 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 13321573 ↗
• InjuryMay 20, 2021Corroded; Material Erosion; Corroded; Material Erosion

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT WAS IMPLANTED WITH AN LIFT C-TAPER FEMORAL HEAD ON HIS RIGHT HIP ON OR ABOUT (B)(6) 2013 AND WAS REVISED ON (B)(6) 2018. IT IS FURTHER ALLEGED THAT HE BEGAN EXPERIENCING SIGNIFICANT PAIN IN HIS HIP IN 2018, MRI DEMONSTRATED "VERY LARGE JOINT INFUSION WITH PROGRESSIVE OSTEOLYTIC CHANGES" AND "LABORATORY RESULTS SHOWED ELEVATED COBALT LEVELS IN HIS BLOOD AS 17.7 MCG/L AND HIS CHROMIUM AS 3.5 MCG/L". IT IS ALLEGED THAT DURING THE REVISION SURGERY ON (B)(6) 2018 THE SURGEON NOTED SIGNS OF FRETTING AND CORROSION AT THE NECK AND REVISED THE ACETABULAR LINER AND THE FEMORAL HEAD.

  Patient problems: Metal Related Pathology

  MAUDE report 11854015 ↗
• InjuryJul 7, 2020Inadequacy of Device Shape and/or Size; Unintended Movement; Migration; Inadequacy of Device Shape and/or Size; Unintended Movement; Migration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO SUBSIDENCE OF THE FEMORAL STEM AFTER A PATIENT FALL. SURGEON REPORTED THAT THE IMPLANTED STEM WAS TOO SMALL FOR THE PATIENT'S ANATOMY AND THAT THE FALL CONTRIBUTED TO SUBSIDENCE. DURING THE REVISION, PITTING WAS NOTED ON THE INNER ARTICULAR SURFACE OF THE POLY LINER. THE SURGEON REPORTED THIS WAS LIKELY CAUSED BY ABRASIVE MATERIAL ON THE FEMORAL HEAD, AND WOULD LIKE THE LINER TO BE INVESTIGATED TO CONFIRM, AND WOULD LIKE THE RESULTS. THE STEM, HEAD, AND LINER WERE REVISED. THE DEVICES ARE ALLEGEDLY AVAILABLE FOR RETURN. THE REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Fall; Injury; Pain

  MAUDE report 10239001 ↗
• InjuryMay 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  POSTOPERATIVE DIAGNOSIS: THE PATIENT UNDERWENT RIGHT TOTAL HIP REPLACEMENT (B)(6) 2018. PATIENT FELL AND X-RAYS PRESENTED FEMUR PERIPROSTHETIC FRACTURE. PATIENT UNDERWENT REVISION ARTHROPLASTY (B)(6) 2018. ALL COMPONENTS EXCHANGED EXCEP CUP.

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

  MAUDE report 8568572 ↗
• InjuryMar 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED AFTER PATIENT FELL IN THE HOSPITAL, SUSTAINING A PERIPROSTHETIC FRACTURE OF THE TROCHANTER OF THE FEMUR.

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

  MAUDE report 7374762 ↗

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