Secur-Fit 1601-05132Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327021264), received between Apr 17, 2019 and May 21, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2019Migration; Migration

  PRIMARY PROCEDURE, LEFT HIP. IT WAS REPORTED THAT A SIZE 5 SECUR-FIT ADVANCED BROACH WAS USED AND SAT PERFECTLY IN SITU. WHEN THE SIZE 5 SECUR-FIT ADVANCED STEM WAS IMPLANTED, IT SUBSIDED. PROCEDURE WAS COMPLETED WITH A SIZE 6 SECUR-FIT ADVANCED STEM. PROCEDURE WAS TO ADDRESS A FEMORAL FRACTURE, THE REP REPORTED THE FRACTURE WAS NOT A FACTOR IN STEM SUBSIDENCE. THOUGH UNLIKELY, IT IS UNKNOWN IF THE SAME BROACH WAS USED AS IN A PREVIOUS PI WHERE THE SAME EVENT OCCURRED WITH THE SAME SURGEON FOR THE SAME SIZE DEVICES (DIFFERENT PATIENTS).

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 8627455 ↗
• InjuryApr 17, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  SALE REP REPORTED, DURING A HEMI ARTHROPLASTY THE PROSTHESIS RECEDED FURTHER THAN INTENDED. SURGEON STATED THE PROSTHESIS APPEARED TO BE SMALLER THAN THE SIZE 5. SURGEON PROCEEDED WITH A SIZE 6 PROSTHESIS AND COMPLETED SURGERY SUCCESSFULLY. IT WAS NOTED BY THE REP THAT THERE WAS A FRACTURE ON THE BONE AND SUSPECTS THAT THE STEM MOVED DUE TO THE FRACTURE. THERE WAS APPROXIMATELY A 5 MINUTE SURGICAL DELAY.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 8523464 ↗