NA 04.168.500SRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982274625), received between Sep 1, 2020 and Jul 23, 2024 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A PATIENT UNDERWENT A REMOVAL OF FEMORAL NECK SYSTEM (FNS) DUE TO SECONDARY FRACTURE POST-OPERATIVE. PATIENT'S FEMUR WAS REVISED TO TROCHANTERIC FIXATION NAIL ADVANCED (TFNA). NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) ANTIROTATION SCREW FOR FEMORAL NECK SYS 100MM LENGTH - STER THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 19811962 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED AN IMPLANT FAILURE OCCURRED POST OPERATIVELY ON AN UNKNOWN DATE. IMPLANT DATE IS UNKNOWN. PATIENT HAD REVISION SURGERY TO CONVERT TO TOTAL HIP ON (B)(6) 2023. THIS REPORT IS FOR ANTIROTATION SCR FEM NECK 100 LNTH - S. THIS PC IS LINKED TO THE INTRAOPERATIVE REVISION EVENTS OCCURRING IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; Physical Asymmetry

  MAUDE report 18355034 ↗
• MalfunctionJun 23, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2022, THE THREE INTERLOCKING PARTS OF THE FEMORAL NECK SYSTEM BROKE APART FROM EACH OTHER WHEN THEY WERE IMPLANTED. THIS REPORT IS FOR AN ANTIROTATION SCREW FOR FEMORAL NECK SYS 100MM LENGTH - STER. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14787095 ↗
• InjuryMay 10, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT REMOVAL OF A FEMORAL NECK SYSTEM AND CONVERSION TO TOTAL HIP ARTHROPLASTY DUE TO THE IMPLANT WAS SUBSEQUENTLY BEGINNING TO CUT OUT. THE PATIENT WAS PREVIOUSLY TREATED FOR A FEMORAL NECK FRACTURE WITH THE FEMORAL NECK SYSTEM ON (B)(6) 2020. THE ANTI-ROTATION SCREW AND BOLT OF THE FNS SYSTEM WERE OBSERVED TO BE CUTTING OUT SUPERIORLY AS THE FEMORAL HEAD COLLAPSED INTO VARUS. THIS REPORT IS FOR ONE (1) ANTI-ROTATION SCR FEM NECK 100 LENGTH - S. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 14345658 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A REMOVAL OF FEMORAL NECK SYSTEM IMPLANTS SURGEON WANTED TO PERFORM A TOTAL HIP ON THIS PATIENT AND NEEDED TO REMOVE THE HARDWARE BEFORE THEY COULD PROCEED WITH THAT PROCEDURE. PATIENT ACHIEVED FULL HEALING WITH THE PREVIOUS FNS IMPLANT AND THERE WERE NO ISSUES RELATING TO THE PREVIOUS PROCEDURE. NO PATIENT CONSEQUENCES HAVE BEEN REPORTED. THIS REPORT IS FOR ONE (1) ANTI-ROTATION SCREW FOR FEMORAL NECK SYS 100MM LENGTH - STER. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11886886 ↗
• InjuryDec 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, WHEN THE SURGEON HAD TO REMOVE THE FEMORAL NECK PLATE DUE TO PAIN, THE LOCKING SCREW WAS LOCKED INTO THE PLATE AND IT WOULD NOT COME OUT SO THE SURGEON USED AN UNKNOWN METAL CUTTING BURR TO CUT INTO THE PLATE. THE SURGEON WAS THEN ABLE TO BACK OUT THE LOCKING SCREW AND WAS ALSO ABLE TO REMOVE THE ANTI-ROTATION SCREW, THE BOLT AND THE PLATE. FRAGMENTS WERE GENERATED AND EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF FIVE (5) MINUTES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) ANTIROTATION SCREW FOR FEMORAL NECK SYS 100MM LENGTH - STER. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 10951275 ↗
• InjuryNov 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF THE FEMORAL NECK SYSTEM (FNS) DEVICES AND SUBSEQUENT TOTAL HIP ARTHROPLASTY DUE TO HIP PAIN AND CYSTIC CHANGES. INITIALLY, THE REPORTED DEVICES WERE IMPLANTED ON (B)(6) 2019 DUE TO A FEMORAL NECK FRACTURE. NONE OF THE REPORTED DEVICES WERE BROKEN; THEY CAME OUT VERY EASY AND DID NOT RESULT IN ANY FURTHER COMPLICATIONS. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR A ANTIROTATION SCREW FOR FNS. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Cyst(s); No Code Available; Pain

  MAUDE report 10852756 ↗
• InjurySep 1, 2020Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT PRESENTED WITH HIP PAIN THREE WEEKS POST-OPERATIVE. ON X-RAY, IMPLANTS SHOW A SUPERIOR CUTOUT OF THE FEMORAL HEAD. THE ORIGINAL DATE OF IMPLANTATION WAS (B)(6) 2020. THE PATIENT WAS HAVING HER FEMORAL NECK SYSTEM (FNS) IMPLANTS REMOVED AND UNDERGOING A HIP HEMI ARTHROPLASTY. THE PROCEDURE AND PATIENT OUTCOMES WERE UNKNOWN. CONCOMITANT DEVICES REPORTED: ANTIROTATION SCREW FOR FEMORAL NECK SYS 100MM LENGTH - STER (PART# 04.168.500S, LOT# 3L32061, QUANTITY# 1). 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 46MM-STERILE (PART# 412.217S, LOT# 2L48457, QUANTITY# 1). BOLT FOR FEMORAL NECK SYSTEM 100MM LENGTH-STERILE (PART# 04.168.300S, LOT# 3L31939, QUANTITY# 1). (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10480434 ↗