Secur-Fit 1601-09127Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327021332), received between Aug 19, 2019 and Sep 15, 2020 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

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.

• InjurySep 15, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO A FEMORAL PERIPROSTHETIC FRACTURE. THE STEM AND HEAD WERE REVISED TO A RESTORATION MODULAR STEM, CERMIC HEAD, 5 SETS OF CABLES, AND A CABLE AND PLATE SET. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD.

  Patient problems: Bone Fracture(s)

  MAUDE report 10533820 ↗
• MalfunctionSep 1, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PRIMARY PROCEDURE, RIGHT HIP. IT WAS REPORTED THAT WHEN THE STEM WAS OPENED, IT APPEARED TO HAVE AN EXCESSIVE AMOUNT OF HA COATING ON IT. A SECOND STEM WAS OPENED AND USED TO COMPLETE THE SURGERY SUCCESSFULLY WITH NO DELAY. THE DEVICE IS ALLEGEDLY AVAILABLE FOR RETURN, AND THE REP CAN PROVIDE THE USAGE SHEET FROM THE CASE, BUT OTHERWISE CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10475776 ↗
• InjuryAug 28, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO FEMORAL PERIPROSTHETIC FRACTURE. THE STEM AND HEAD WERE REVISED. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED HEAD, PROVIDED THE PRIMARY AND REVISION USAGE SHEETS, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 10464560 ↗
• InjuryFeb 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS SEEN BY ANOTHER SURGEON AND HAD A REOPERATION ON HER LEFT HIP (STUDY DEVICE SIDE). SURGEON PERFORMED A HIP ARTHROSCOPY WITH LYSIS OF ADHESIONS, TROCHANTERIC BURSECTOMY, ILIOTIBIAL BAND RELEASE, AND PRP INJECTION TO THE ABDUCTOR TENDON. THE STUDY DEVICE WAS NOT REVISED. PATIENT HAS HAD ONGOING BURSITIS AND REPORTED PAIN SINCE (B)(6) 2018. DR. DOES NOT BELIEVE THE STUDY DEVICE IS THE CAUSE OF THE REOPERATION.

  Patient problems: Injury

  MAUDE report 9734815 ↗
• InjuryAug 19, 2019Osseointegration Problem; Osseointegration Problem

  REVISION HIP SURGERY FOR ASEPTIC LOOSENING OF FEMORAL COMPONENT. UPDATE 23/JULY/2019 WG: AS REPORTED IN HOW WAS ISSUE NOTICED: PATIENT COMPLAINED OF PAIN CONFIRMED ON X-RAY.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 8905613 ↗