NA 412.216SRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982275431), received between Nov 17, 2020 and Aug 18, 2025 — classified as 2 deaths, 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6)., 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH LOCKING SCREW. WHEN THE SURGEON ATTEMPTED TO INSERT INTO THE LATERAL LOCKING OF FNS PLATE, HE INSERTED THE LOCKING SCREW IN QUESTION WHILE PRESSING DOWN ON THE DEVICE TO PREVENT THE PLATE FROM FLOATING. HOWEVER, EXCESSIVE PRESSURE CAUSED THE DEVICE TO SHIFT, AND THE LOCKING SCREW IN QUESTION WAS INSERTED IN A DIRECTION DIFFERENT FROM THE DRILLED HOLE. THE LOCKING SCREW IN QUESTION BECAME LOCKED DURING INSERTION, SO THE SURGEON USED A HAMMER TO FIRMLY BITE THE TIP OF THE DRIVER BEFORE REMOVING IT. HOWEVER, THE NEXT TIME THE DRIVER SHAFT AND SCREW HEAD BECAME TIGHTLY STUCK, SO THE SURGEON USED PLIERS AND A HAMMER TO REMOVE THE LOCKING SCREW IN QUESTION FROM THE DRIVER SHAFT. THE PART THAT HAD BEEN BITTEN BY THE PLIERS BECAME DEFORMED, SO A NEW SCREW WAS USED TO FIX IT, AND THE SURGERY WAS COMPLETED. ALTHOUGH THE LENGTH OF THE NEW SCREW WAS 2 MM LONGER THAN THE LOCKING SCREW IN QUESTION, THE SURGEON DETERMINED THAT IT WAS THE APPROPRIATE LENGTH EVEN UNDER INTRAOPERATIVE FLUOROSCOPY, SO THE WOUND WAS CLOSED AS IS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES SURGICAL DELAY. NO FURTHER INFOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22827726 ↗
• MalfunctionFeb 13, 2025Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DEVICES WERE UNABLE TO STERILIZE/ASSEMBLE. CHIPPING AND CRACKING. UNABLE TO USE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381271 ↗
• MalfunctionFeb 13, 2025Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DEVICES WERE UNABLE TO STERILIZE/ASSEMBLE. CHIPPING AND CRACKING. UNABLE TO USE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381270 ↗
• MalfunctionFeb 13, 2025Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DEVICES WERE UNABLE TO STERILIZE/ASSEMBLE. CHIPPING AND CRACKING. UNABLE TO USE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381269 ↗
• MalfunctionFeb 13, 2025Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT THE DEVICES WERE UNABLE TO STERILIZE/ASSEMBLE. CHIPPING AND CRACKING. UNABLE TO USE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED FOR REPORTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381260 ↗
• InjurySep 22, 2023Migration; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN ORIF SURGERY WITH FNS IMPLANTS FOR A FEMORAL NECK FRACTURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER SURGERY, CUT-OUT OCCURRED. THE FNS IMPLANTS WILL BE REMOVED, AND A REVISION THA WAS SCHEDULED TO BE PERFORMED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 44MM-STERILE. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17804347 ↗
• DeathNov 10, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT RIGHT HIP HEMIARTHROPLASTY AND REMOVAL OF THE HARDWARE. UPON INSPECTION OF THE HARDWARE THE DEPUY SYNTHES FEMORAL NECK SYSTEM HAD BROKEN COMPLETELY THROUGH THE PLATE. THE PATIENT STRUGGLED FROM THIS PROCEDURE AND SUFFERED SIGNIFICANT SWELLING IN HIS BILATERAL LOWER EXTREMITIES WHICH WAS CAUSED BY DEEP VEIN THROMBOSIS IN HIS POPLITEAL VEIN. THE PATIENT SUBSEQUENTLY DEVELOPED AN INFECTION WHICH REQUIRED A THIRD PROCEDURE TO REMOVE THE HARDWARE AND PUT IN AN ANTIBIOTIC SPACER ON (B)(6) 2021. ON (B)(6) 2021 THE PATIENT DIED DUE TO CARDIAC ARREST, ANEMIA POST OP, SEPTIC RIGHT HIP AND THROMBOSIS OF THE LEFT ARM AND RIGHT LEG. ON OR ABOUT DECEMBER 08, 2020 THE PATIENT SUFFERED A FALL AT HIS HOME, WHILE CARRYING A FEW GALLONS OF WATER ON HIS PROPERTY WHICH INCLUDED A SLOPING DRIVEWAY. X-RAY REPORTED A RIGHT INTERTROCHANTERIC FRACTURE AND A CT WHICH CONCLUDED THAT HE HAD IMPACTED COMMINUTED RIGHT INTERTROCHANTERIC FRACTURE. ON (B)(6) 2020 THE PATIENT UNDERWENT OPEN TREATMENT OF THE RIGHT FEMORAL NECK FRACTURE WITH A SCREW AND SIDE PLATE. ON (B)(6) 2021 THE PATIENT COMPLAINTS OF WORSENING RIGHT HIP PAIN AND LOWER EXTREMITY EDEMA. STAT

  Patient problems: Pain; Post Operative Wound Infection; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 15769648 ↗
• DeathNov 10, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT RIGHT HIP HEMIARTHROPLASTY AND REMOVAL OF THE HARDWARE. UPON INSPECTION OF THE HARDWARE THE DEPUY SYNTHES FEMORAL NECK SYSTEM HAD BROKEN COMPLETELY THROUGH THE PLATE. THE PATIENT STRUGGLED FROM THIS PROCEDURE AND SUFFERED SIGNIFICANT SWELLING IN HIS BILATERAL LOWER EXTREMITIES WHICH WAS CAUSED BY DEEP VEIN THROMBOSIS IN HIS POPLITEAL VEIN. THE PATIENT SUBSEQUENTLY DEVELOPED AN INFECTION WHICH REQUIRED A THIRD PROCEDURE TO REMOVE THE HARDWARE AND PUT IN AN ANTIBIOTIC SPACER ON (B)(6) 2021. ON (B)(6) 2021 THE PATIENT DIED DUE TO CARDIAC ARREST, ANEMIA POST OP, SEPTIC RIGHT HIP AND THROMBOSIS OF THE LEFT ARM AND RIGHT LEG. ON OR ABOUT (B)(6) 2020 THE PATIENT SUFFERED A FALL AT HIS HOME, WHILE CARRYING A FEW GALLONS OF WATER ON HIS PROPERTY WHICH INCLUDED A SLOPING DRIVEWAY. X-RAY REPORTED A RIGHT INTERTROCHANTERIC FRACTURE AND A CT WHICH CONCLUDED THAT HE HAD IMPACTED COMMINUTED RIGHT INTERTROCHANTERIC FRACTURE. ON (B)(6) 2020 THE PATIENT UNDERWENT OPEN TREATMENT OF THE RIGHT FEMORAL NECK FRACTURE WITH A SCREW AND SIDE PLATE. ON (B)(6) 2021 THE PATIENT COMPLAINTS OF WORSENING RIGHT HIP PAIN AND LOWER EXTREMITY EDEMA. STATED THE

  Patient problems: Pain; Post Operative Wound Infection; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 15769644 ↗
• InjuryOct 1, 2022Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT ORIF SURGERY WITH FNS FOR A FEMORAL NECK FRACTURE. AFTER SURGERY, SHORTENING OF THE FEMORAL NECK WAS CONFIRMED ON (B)(6) 2022 AND AGAIN IN (B)(6) 2022. ON (B)(6) 2022, THE SCREW BROKE AT ITS NECK, AND CRUSHING OF THE POSTERIOR PART OF THE FEMORAL NECK WAS CONFIRMED AS WELL. A REVISION SURGERY VIA THA WILL BE PERFORMED AFTER REMOVING THE FNS IMPLANTS. THIS REPORT IS FOR A 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 44MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

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

  MAUDE report 15525637 ↗
• 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 (1) 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 44MM-STERILE. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

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

  MAUDE report 11887122 ↗
• 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 5.0MM TITANIUM (TI) LOCKING SCREW 44MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

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

  MAUDE report 10852819 ↗