Secur-Fit 1601-07127Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327021295), received between Apr 3, 2017 and Mar 15, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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.

• InjuryMar 15, 2021Adverse 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. PATIENT MOVED IN BED, FELT A SHARP PAIN, AND THEN PRESENTED WITH A FEMORAL PERIPROSTHETIC FRACTURE. A SIZE 7 SECUR-FIT STEM AND 36MM V40 LFIT HEAD WERE REVISED TO A SIZE 7 OMNIFIT HFX STEM AND 36MM C-TAPER HEAD WITH A SPACER AND TWO DALL MILES CABLES. THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD. REP CONFIRMED THAT OTHER THAN THE ATTACHED REVISION USAGE SHEET, NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Hip Fracture

  MAUDE report 11490186 ↗
• InjuryJun 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "PATIENT WAS SEEN BY ANOTHER ORTHOPAEDIC SURGEON IN LONG ISLAND. SHE REPORTED PAIN TO THE SURGEON AND HAD LABS DRAWN. THE LABS REVEALED ELEVATED COBALT AND CHROMIUM LEVELS. THE PATIENT REPORTED THAT THE FEMORAL HEAD WAS EXCHANGED BUT NO MEDICAL RECORDS COULD BE OBTAINED BY CLINICAL STUDY STAFF. PER CONVERSATION ON (B)(6) 2018 WITH THE CLINICAL STUDY STAFF, THE PATIENT REPORTED NO PAIN IN HER REVISED HIP".

  Patient problems: Inflammation; Injury; Pain; Reaction

  MAUDE report 7647495 ↗
• InjuryJun 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "PATIENT, A STUDY SUBJECT IN THE (B)(6) ADVANCED POST-MARKET CLINICAL STUDY UNDERWENT PRIMARY SURGERY ON (B)(6) 2018. INTRAOPERATIVELY, THE SURGEON IDENTIFIED A NONDISPLACED FRACTURE OF THE CALCAR BOTH ANTERIORLY AND POSTERIORLY. THE PHYSICIAN PROPHYLACTICALLY PLACED CABLES BELOW THE LESSER TROCHANTER. SURGEON STATED THAT POSTOPERATIVE X-RAYS DEMONSTRATED NO EVIDENCE OF THE FRACTURE. SIX WEEK POSTOPERATIVE VISIT DATA HAS NOT BEEN ENTERED INTO THE STUDY DATABASE. PER SURGEON, IT IS NOT POSSIBLE TO KNOW WHETHER THE FRACTURE WAS SUSTAINED DURING BROACHING OR DURING PLACEMENT OF THE STEM (STUDY DEVICE)".

  Patient problems: Bone Fracture(s)

  MAUDE report 7570204 ↗
• InjuryAug 14, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT PRESENTED WITH THIGH PAIN A YEAR AFTER HIP REPLACEMENT, BONE SCAN WAS POSITIVE AROUND THE STEM. PATIENT WAS REVISED DUE TO PAIN. FURTHER INFORMATION, MEDICAL RECORDS AND X-RAYS ARE UNAVAILABLE DUE TO HOSPITAL.

  Patient problems: Injury; Pain

  MAUDE report 6793048 ↗
• InjuryApr 3, 2017Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Insufficient Device Problem Information

  SALES REP REPORTED PATIENT IS MENTALLY CHALLENGED, NOT SURE IF SHE SUFFERED A FALL & FRACTURE.

  Patient problems: Bone Fracture(s); Fall; Injury; No Known Impact Or Consequence To Patient

  MAUDE report 6452930 ↗