Secur-Fit 1601-10127Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327021356), received between Jul 29, 2019 and Oct 20, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (1 report).

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.

• InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HEMI HIP WAS REVISED DUE TO A GREATER TROCHANTERIC FRACTURE. THE HEMI HIP WAS REMOVED, AND A NEW HEMI HIP INCLUDING A RESTORATION MODULAR STEM CONSTRUCT WAS IMPLANTED. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED FEMORAL AND BIPOLAR HEADS, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 23334635 ↗
• InjuryMay 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DISLOCATED TOTAL LEFT HIP. SURGEON REPLACED FEMORAL STEM, FEMORAL HEAD AND MDM POLY INSERT. THE POLY HEAD CAME OUT OF THE METAL CUP LINER. SURGEON CHOSE TO REMOVE AND REPLACE STEM TO GIVE HIM THE ABILITY TO SHORTEN THE OVERALL STEM/NECK/ HEAD LENGTH.

  Patient problems: Joint Dislocation

  MAUDE report 16951315 ↗
• MalfunctionFeb 3, 2021Device Difficult to Setup or Prepare; Manufacturing, Packaging or Shipping Problem; Device Difficult to Setup or Prepare; Manufacturing, Packaging or Shipping Problem

  PRIMARY PROCEDURE, RIGHT HIP. IT WAS REPORTED THAT WHEN THE SECUR-FIT ADVANCED STEM WAS OPENED, THE HA COATING AT THE PROXIMAL END OF THE STEM SEEMED TOO THICK. ANOTHER STEM WAS OPENED AND USED TO COMPLETE THE SURGERY SUCCESSFULLY WITH NO DELAY. REP WAS PRESENT FOR AND WITNESSED THE PROCEDURE. REP PROVIDED A PICTURE OF THE DEVICE (WHICH IS ALLEGEDLY AVAILABLE FOR RETURN) AND THE SALES ORDER FOR THE CASE AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11276741 ↗
• InjuryJan 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT'S HIP WAS REVISED DUE TO FEMORAL PERIPROSTHETIC FRACTURE. SURGEON REPORTED FRACTURE WAS SUFFERED IN A FALL. THE STEM AND HEAD WERE REVISED TO A RESTORATION MODULAR STEM CONSTRUCT WITH ANOTHER FEMORAL HEAD AND CABLES. REP PROVIDED PRIMARY AND REVISION USAGE, CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD, AND ALSO CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 11107763 ↗
• InjuryJul 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "[PATIENT'S LEFT HIP] WAS REVISED FOR PAIN".

  Patient problems: Injury; Pain

  MAUDE report 8836652 ↗