NA 04.168.495SRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982274618), received between Jun 4, 2019 and Aug 8, 2025 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 2025Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY FOR FEMORAL NECK FRACTURE WITH FNS. THERE WERE NO PROBLEMS WITH INTRAOPERATIVE IMAGING, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. HOWEVER, A POSTOPERATIVE X-RAY SHOWED THAT THE FEMORAL HEAD APPEARED TO HAVE CUT-OUT, SO A CT SCAN WAS PERFORMED. THE CT SCAN RESULTS CONFIRMED THAT CUT-OUT OCCURRED. THEREFORE, A REVISION SURGERY WAS PERFORMED IMMEDIATELY AND THE NECK BOLT AND ANTIROTATION SCREW WERE REPLACED WITH ONES 5 MM SHORTER IN SIZE. THE SURGEON WAS OPERATING IN A SLIGHTLY EXTERNALLY ROTATED POSITION AND WAS NOT ABLE TO CHECK IMPLANTS PROPERLY. HE ALSO MENTIONED THAT THE IMPLANTS HAD BEEN INSERTED SLIGHTLY BELOW THE MIDDLE OF THE HEAD OF THE BONE, WHICH MAY HAVE PARTIALLY CUT-OUT THE HEAD OF THE BONE WHEN THE NEAR-LIMIT LENGTH WAS SELECTED. THE SURGERY WAS COMPLETED WITH 70 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22748726 ↗
• MalfunctionAug 4, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE FNS ANTI ROTATION SCREW WAS NOT LOCKING INTO THE BOLT. THERE WAS NO BREAKAGE OR DELAY IN PROCEDURE. TORQUE LIMITER WAS UNABLE TO FULLY TIGHTEN ANTI ROTATION SCREW IN GOOD, YOUNG BONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22698966 ↗
• InjuryFeb 12, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD A GROUND-LEVEL FALL AND SUFFERED A BROKEN HIP AFTER A BUSY DAY AT WORK TEACHING YOGA. DESPITE HER PAIN, PATIENT INITIALLY ATTRIBUTED IT TO FATIGUE. BUT, AS THE DISCOMFORT WORSENED, SHE KNEW SOMETHING WAS WRONG. BY 10AM, SHE FOUND HERSELF IN THE EMERGENCY ROOM, WHERE SHE WAS DIAGNOSED WITH A BROKEN FEMUR. THE SURGEON PERFORMED AN OPEN REDUCTION WITH INTERNAL FIXATION ON HER HIP AND THE PATIENT UNDERWENT REHABILITATION, DILIGENTLY ATTENDING PHYSICAL THERAPY SESSIONS AT THE HOSPITAL AND LATER AT HOME. A MONTH POST-SURGERY, X-RAY REVEALED COMPLICATIONS FROM THE INITIAL SURGERY. THE SCREW HAD SNAPPED. HARDWARE REMOVED FROM LEFT HIP CONSISTING OF THREE METALLIC MEDIAL DEVICES AND METALLIC SCREW.

  Patient problems: Insufficient Information

  MAUDE report 21363215 ↗
• InjuryAug 8, 2023Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FNS (FEMORAL NECK SCREW) CUTOUT. DURING A REMOVAL PROCEDURE, THE FNS LOCKING SCREW WAS COLD WELDED INTO THE PLATE. THE PATIENT HAD AN ADDITIONAL FRACTURE DURING REMOVAL OF THE SCREW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, BUT TOOK LONGER THAN EXPECTED ACCORDING TO THE SURGEON. THE PATIENT OUTCOME WAS SATISFACTORY. THIS REPORT INVOLVES ONE ANTIROTATION SCREW FOR FEMORAL NECK SYS 95MM LENGTH - STERIL. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 17479975 ↗
• InjuryAug 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2023, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A FEMORAL NECK FRACTURE WITH THE FEMORAL NECK SYSTEM. ON (B)(6) 2023 THE PATIENT SUSTAINED A STANDING HEIGHT FALL; X RAY IMAGES TAKEN REVELED A FRACTURE DISTAL TO THE FEMORAL NECK SYSTEM (FNS) PLATE. THE PATIENT WAS BROUGHT TO THE OR ON (B)(6) 2023 FOR REMOVAL OF THE FNS AND REVISION TO LONG TFNA NAIL. THIS REPORT IS FOR ONE (1) ANTIROTATION SCREW FOR FEMORAL NECK SYS 95MM LENGTH - STERILE. THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 17477016 ↗
• InjuryAug 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A HARDWARE REMOVAL AND REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE. PATIENT WAS TREATED WITH A FEMORAL NECK SYSTEM ON (B)(6) 2021 COMPLAINED OF CONTINUED PAIN POSTOPERATIVELY. A CT SCAN REVEALED A FRACTURE DISTAL TO THE PLATE OF THE FNS. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM ON (B)(6) 2021; THE FNS HARDWARE WAS REMOVED AND LONG TROCHANTERIC FIXATION NAIL, HELICAL BLADE, AND LOCKING SCREW WERE INSERTED. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES FIVE(5) DEVICES. THIS REPORT IS FOR (1) ANTIROTATION SCR FEM NECK 95 LNTH -S. THIS REPORT IS 5 OF 5 FOR (B)(4)

  Patient problems: Bone Fracture(s)

  MAUDE report 12368400 ↗
• InjuryJan 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, A HARDWARE REMOVAL AND OPEN REDUCTION INTERNAL FIXATION (ORIF) WITH AN INTRAMEDULLARY NAIL WAS PERFORMED DUE TO SUB-TROCHANTERIC FEMUR FRACTURE. THE PATIENT ORIGINALLY UNDERWENT SURGERY FOR DISPLACED FEMORAL NECK FRACTURE ON (B)(6) 2020. AT THAT TIME, THE PATIENT WAS TREATED WITH A FEMORAL NECK SYSTEM. PATIENT SUBSEQUENTLY SLIPPED AND FELL AT HOME ON (B)(6) 2020 AND SUSTAINED A COMMINUTED SUB-TROCHANTERIC FEMUR FRACTURE. THE FNS HARDWARE WAS REMOVED AND THE PATIENT WAS IMPLANTED WITH FEMORAL RECON NAIL. THIS REPORT IS FOR ONE (1) ANTIROTATION SCREW FOR FEMORAL NECK SYS 95MM LENGTH - STERILE. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 11195411 ↗
• InjuryJun 29, 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 A REMOVAL OF THE FEMORAL NECK SYSTEM (FNS) DUE TO AVASCULAR NECROSIS (AVN). INITIALLY, THE PATIENT HAD FNS IMPLANTATION ON (B)(6) 2020. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 30 MINUTE SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS PRODUCT COMPLAINT, (B)(4), IS RELATED TO (B)(4). (B)(4) CAPTURES THE POST-OP EVENT WHERE THE PATIENT UNDERWENT A REMOVAL OF THE FEMORAL NECK SYSTEM (FNS) DUE TO AVASCULAR NECROSIS (AVN), WHILE (B)(4) WILL CAPTURE THE INTRA-OP EVENT WHERE THE SURGEON EXPERIENCED DIFFICULTY IN THE REMOVAL OF THE FEMORAL NECK SYSTEM (FNS) HARDWARE DUE TO THE LOCKING SCREW BEING COLD WELDED TO THE PLATE, A REMOVAL TOOL WAS ALSO BENT DURING THE REMOVAL PROCESS. CONCOMITANT DEVICES REPORTED: FEMORAL NECK SYSTEM PLATE 1 HOLE ¿ STERILE (PART NUMBER 04.168.000S, LOT UNKNOWN, QUANTITY 1), BOLT FOR FEMORAL NECK SYSTEM 95MM LENGTH-STERILE (PART NUMBER 04.168.295S, LOT UNKNOWN, QUANTITY 1), 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 36MM-STERILE (PART NUMBER 412.212S, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES 1 ANTIROTATION SCREW FOR FEMORAL NECK SYS 95MM LENGTH - STERILE. THIS IS REPORT 3 OF

  Patient problems: Necrosis; No Code Available

  MAUDE report 10206452 ↗
• InjuryFeb 24, 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 THE REMOVAL OF AN UNKNOWN FEMORAL NECK SYSTEM (FNS) PLATE, TITANIUM LOCKING SCREW SELF-TAPPING, ANTIROTATION SCREW FOR FNS AND BOLT FOR FNS DUE TO NONUNION. IT WAS ORIGINALLY IMPLANTED ON (B)(6) 2019. ALL THE IMPLANTS ARE REMOVED SUCCESSFULLY. PATIENT STATUS WAS UNKNOWN. THIS REPORT IS FOR ONE ANTIROTATION SCREW FOR FEMORAL NECK SYS 95MM LENGTH - STERILE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9744446 ↗
• InjuryAug 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A SURGERY FOR THE FEMORAL NECK FRACTURE WITH FEMORAL NECK SYSTEM (FNS) AND THE LOCKING SCREW. ON (B)(6) 2019 THE PATIENT STARTED PARTIAL WEIGHT BEARING AND FROM (B)(6) 2019 PATIENT STARTED FULL WEIGHT BEARING. ON (B)(6) 2019 THE HOSPITAL CONFIRMED THE DISPLACEMENT AT THE FRACTURE SITE AND CONSIDERED BIARTICULAR HIP PROSTHESIS SURGERY. ON (B)(6) 2019 THE PATIENT UNDERWENT THE REMOVAL OF FNS AND BIARTICULAR HIP PROSTHESIS SURGERY. DURING THE REMOVAL OF FNS, THE SURGEON COULD NOT REMOVE THE DISTAL LOCKING SCREW. THE SURGEON REMOVED THE SCREW WITH A CARBIDE DRILL AND REMOVAL INSTRUMENTS. THE SURGERY WAS DELAYED BY LESS THAN THIRTY (30) MINUTES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT CAPTURES THE POST OP EVENT FOR DISPLACEMENT AT THE FRACTURE SITE AND CONSIDERED BIARTICULAR HIP PROSTHESIS SURGERY WHILE RELATED COMPLAINT (B)(4) CAPTURES THE INTRAOPERATIVE EVENT FOR REMOVAL OF FNS AND BIARTICULAR HIP PROSTHESIS SURGERY. THIS REPORT IS FOR ONE (1) ANTI-ROTATION SCREW FOR FEMORAL NECK SYS 95 MM LENGTH - STERILE. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 8902612 ↗
• InjuryJul 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY DUE TO A SUBTROCHANTERIC FRACTURE SUBSEQUENT TO THEIR INITIAL FRACTURE. THE PATIENT¿S ORIGINAL INJURY HAD NOT HEALED, AND A SECOND FRACTURE OCCURRED IN THE FEMUR, JUST DISTAL TO THE SIDE PLATE. THE SURGEON REMOVED ALL IMPLANTS; FEMORAL NECK SYSTEM PLATE, ANTI-ROTATION SCREW, FEMORAL NECK BOLT, 40 MM TITANIUM LOCKING SCREW AND 30 MM TITANIUM LOCKING SCREW. PATIENT WAS REVISED WITH A NON-SYNTHES GAMMA NAIL. ORIGINALLY, THE PATIENT WAS TREATED FOR A FEMORAL NECK FRACTURE ON (B)(6) 2019. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A ANTI-ROTATION SCREW FOR FEMORAL NECK SYSTEM. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s); Impaired Healing; No Code Available

  MAUDE report 8823398 ↗
• InjuryJun 4, 2019Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2019, THE BOLT FOR FEMORAL NECK SYSTEM-STERILE, FEMORAL NECK SYSTEM PLATE-STERILE, ANTIROTATION SCREW FOR FEMORAL NECK SYSTEM-STERILE & TITANIUM LOCKING SCREW SELF-TAPPING STARDRIVE-STERILE WERE REMOVED DUE TO DEVICE CUT OF FEMORAL HEAD AND WAS REVISED TO A TOTAL HIP ARTHROPLASTY. THE FEMORAL NECK SYSTEM (FNS) WAS IMPLANTED ON (B)(6) 2019, WITHOUT COMPLICATIONS. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICES REPORTED: FEMORAL NECK SYSTEM PLATE 1 HOLE - STERILE (PART # 04.168.000S, LOT # L885836, QUANTITY # 1), 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 46MM-STERILE (PART # 412.217S, LOT # L896483, QUANTITY # 1). THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 8667550 ↗