Secur-Fit 1601-08127Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613327021318), received between Feb 7, 2018 and Jul 24, 2025 — classified as 12 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2025Loss of Osseointegration; Loss of Osseointegration

  PT. REPORTED; HAD RIGHT HIP IMPLANT IN (B(6) 2022 AND HAD MANY PROBLEMS WITH THE IMPLANT. PT. MENTIONED LOOSENING, IMMOBILITY, BURSITIS AND WEAR. IMPENDING REVISION TO REPLACE JOINT AND THE LINER DUE TO WEAR.

  Patient problems: Ambulation or Postural Difficulties; Bursitis; Inadequate Osseointegration

  MAUDE report 22599722 ↗
• InjurySep 26, 2024Adverse 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 A FEMORAL PERIPROSTHETIC FRACTURE. A SECUR-FIT STEM AND CERAMIC HEAD WERE REVISED TO A RESTORATION MODULAR STEM, A NEW FEMORAL HEAD, AND DALL/MILES CABLES. REP CONFIRMED THAT THERE WERE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 20309748 ↗
• InjuryApr 30, 2024Corroded; Corroded

  IT WAS REPORTED BY CLAIMANT'S COUNSEL THAT THE PATIENT UNDERWENT LEFT THA ON (B)(6) 2014, AND WAS IMPLANTED WITH AN LFIT V40 FEMORAL HEAD AND A SECUR FIT ADVANCED STEM. RECENTLY HE FELT SOMETHING MOVING AND PRESENTED WITH LEFT HIP DISCOMFORT. HE WAS REVISED ON (B)(6) 2023, AND INTRAOPERATIVELY THE SURGEON NOTED "TRUNNION WAS VISUALIZED AND WAS CORRODED AND DEFORMED".

  Patient problems: Discomfort

  MAUDE report 19215331 ↗
• InjuryDec 8, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO A FEMORAL PERIPROSTHETIC FRACTURE SUSTAINED IN A FALL LEADING TO STEM SUBSIDENCE. REP CAN PROVIDE THE PRIMARY AND REVISION USAGE, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 15940305 ↗
• InjuryAug 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE REVISION OF THE PATIENT'S HIP ON (B)(6) 2022. IN PROVIDING ADDITIONAL INFORMATION FOR A REVISION OF THE PATIENT'S HIP ON (B)(6) 2022, REP PROVIDED A REVISION USAGE SHEET FROM (B)(6) 2022. SPOKE TO THE REPORTING REP, WHO IS NOT THE REP WHO WAS PRESENT FOR THE PROCEDURE. A SECUR-FIT ADVANCED STEM AND FEMORAL HEAD WERE REVISED DUE TO FEMORAL PERIPROSTHETIC FRACTURE. REPORTING REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD.

  Patient problems: Bone Fracture(s)

  MAUDE report 15257452 ↗
• InjuryNov 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE REVISION ON (B)(6) 2021. IN PROVIDING INFORMATION FOR A HIP REVISION ON (B)(6) 2021, REP PROVIDED A USAGE SHEET FOR A REVISION ON (B)(6) 2021. REP CONFIRMED THE PATIENT WAS REVISED DUE TO A CALCAR FRACTURE, AND THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD. REP RE-CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 12874540 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN IMPLANTING A STEM IN A PRIMARY RIGHT HIP PROCEDURE, THE PATIENT'S FEMUR FRACTURED. SURGEON USED A CABLE TO ADDRESS THE FRACTURE AND RETAINED THE FEMORAL STEM.

  Patient problems: Bone Fracture(s)

  MAUDE report 11161928 ↗
• InjuryJan 8, 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 DUE TO SUBSIDENCE OF THE FEMORAL STEM CAUSED BY DISPLACEMENT OF A PRIOR INTRA-OP FEMORAL FRACTURE. A STEM, HEAD AND CABLE WERE REVISED TO A LARGER STEM, GRIP PLATE CABLES, AND NEW FEMORAL HEAD. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD, PROVIDED THE REVISION USAGE SHEET, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 11140574 ↗
• InjuryOct 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT'S HIP WAS REVISED. AS REPORTED BY REP: "SUBSIDED FEMORAL HIP STEM (RIGHT SIDE)." A STEM, HEAD, AND INSERT WERE REVISED.

  Patient problems: Insufficient Information

  MAUDE report 10761735 ↗
• InjuryOct 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR THE INTRA-OPERATIVE FRACTURE DURING THE PRIMARY RIGHT HIP PROCEDURE. AFTER WASTING A SECUR-FIT STEM WHICH HAD AN ALLEGED HA COATING ISSUE, THE SECOND STEM WAS OPENED. WHEN THE STEM WAS BEING INSERTED, A FEMORAL FRACTURE WAS OBSERVED. THE TIME AND CAUSE OF THE FRACTURE ARE UNKNOWN. SURGERY WAS CONVERTED TO IMPLANT A RESTORATION MODULAR STEM CONSTRUCT WITH TWO SETS OF DALL-MILES CABLES. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 20-30 MINUTES (IN ADDITION TO THE PREVIOUSLY REPORTED SURGICAL DELAY FOR THE FIRST WASTED STEM). REP PROVIDED THE CASE USAGE SHEET, AND MAY BE ABLE TO OBTAIN THE OPERATIVE REPORT AND X-RAYS ONLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 9215089 ↗
• MalfunctionOct 21, 2019Mechanical Problem; Manufacturing, Packaging or Shipping Problem; Mechanical Problem; Manufacturing, Packaging or Shipping Problem

  PRIMARY PROCEDURE, RIGHT HIP. IT WAS REPORTED THAT AS THE SECUR-FIT ADVANCED STEM WAS BEING IMPLANTED AND WAS ABOUT 1/2 WAY UP THE HA COATING, THE PA OBSERVED THE STEM LOOKED UNUSUAL. THE STEM WAS REMOVED AND INSPECTED. THE HA COATING SEEMED TO BE MUCH THICKER THAN NORMAL, WITH THE NORMALIZATION LINES ON THE SIDES NEARLY FILLED IN. ANOTHER STEM (SAME CATALOG, DIFFERENT LOT) WAS OPENED AND LOOKED COMPLETELY DIFFERENT THAN THE FIRST STEM, AND LOOKED NORMAL. THERE WAS AN APPROXIMATE 5 MINUTE SURGICAL DELAY TO RETRIEVE THE SECOND STEM. REP WAS PRESENT FOR THE PROCEDURE AND WITNESSED THE STEM. REP PROVIDED THE USAGE SHEET SHOWING THE WASTED STEM, AND PICTURES OF THE DEVICE, WHICH IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9214839 ↗
• InjuryMar 22, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  AS REPORTED: "[PATIENT] FELL AFTER HER {RIGHT} HIP REPLACEMENT. HER STEM SUBSIDED. [SURGEON] REMOVED THE SECUR FIT ADVANCED STEM, AND REPLACED IT WITH RESTORATION MODULAR STEM".

  Patient problems: Fall; Injury

  MAUDE report 7361106 ↗
• InjuryFeb 7, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT PATIENT'S LEFT HIP WAS REVISED. REVISION IMPLANTS WERE A STEM, HEAD, AND 4 BEADED CABLES.

  Patient problems: Injury

  MAUDE report 7249891 ↗