NA 04.168.290SRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886982274748), received between Jan 16, 2019 and Nov 1, 2023 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2023Migration; Migration

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE FNS IN QUESTION. DURING THE PROCEDURE, A GUIDEWIRE WAS INSERTED TO THE INDICATED POSITION AND MEASURED. THE NECK BOLT WAS INSERTED BY REAMING WITH A REAMER SET TO THE MEASURED VALUE; HOWEVER, IT HAD ADVANCED BEYOND THE REAMED TIP. THE PHYSICIAN DETERMINED THAT THE REAMER BARELY PENETRATED, SO THEY PROCEEDED WITH THE PROCEDURE AND CLOSED THE WOUND. WHEN THE PATIENT WAS MOVED TO BED AND THE HIP JOINT WAS OPERATED ON, THE IMPLANT WAS FOUND TO BE PROTRUDING. THE NECK BOLT AND ANTI-ROTATION SCREW WERE REPLACED WITH SHORTER SIZE. THE PATIENT OUTCOME IS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A BOLT FOR FEMORAL NECK SYSTEM 90MM LENGTH-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18047545 ↗
• 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 BOLT FOR FEMORAL NECK SYSTEM 90MM LENGTH-STERILE. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 17479966 ↗
• InjuryJul 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2023, THE SURGEON TOOK OUT THE PLATE, BOLT, ANTI ROTATIONAL AND LOCKING SCREWS AND REVISED IT WITH A LONG FEMUR IM NAIL, (SMITH AND NEPHEW INERTAN ). THE ACTUAL FNS PLATE, BOLT AND SCREWS OR THE COMPLETE IMPLANT CONSTRUCT WAS NOT DAMAGED AT TIME OF EXTRACTION; WHEN THE EXTRACTION TOOK PLACE, IT WAS SEEMED THE PATIENT FELL AND FRACTURED HER FEMUR BELOW THE PLATE OR BELOW THE MOST DISTAL SCREWS IN THE PLATE. THIS REPORT IS FOR ONE (1) BOLT F/FEM NECK SYST F/CONSTRUCTL. 90 TA. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Fall; Limb Fracture

  MAUDE report 17248845 ↗
• InjuryJan 10, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2021, A BOLT AND ANTI-ROTATION SCREW WERE PLACED. AFTER FEW DAYS THE PATIENT WAS COMPLAINING OF HIP PAIN. AFTER LOOKING AT THE X-RAYS, THE DEVICE WAS PERFORATED AT THE JOINT SURFACE. AT THAT TIME PHYSICIAN DECIDED TO REVISE THE DEVICE TO A SHORTER LENGTH. PATIENT WAS BROUGHT BACK IN FOR REVISION SURGERY TO REPLACE LONG BOLT AND SCREW. THIS REPORT IS FOR (1) BOLT FOR FEMORAL NECK SYS 90 LENGTH-SILE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 13213266 ↗
• InjuryAug 25, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT HAD AN EX-PLANTATION OF A FAILED FEMORAL NECK SYSTEM, ORIGINAL DATE OF THE SURGERY WAS (B)(6) 2020. THE PATIENT HAS A HISTORY OF SUBSTANCE ABUSE. NO FRAGMENTATION WAS OBSERVED BESIDES THE SPLIT IN THE BOLT FOR FEMORAL NECK SYSTEM AND ANTI-ROTATION SCREW. CONCOMITANT DEVICE REPORTED: FEMORAL NECK SYSTEM (PART: 04.268.000S; LOT: 22P9146; QUANTITY: 1); 5.0MM LOCKING SCREWS, WITH T25 STARDRIVE (PART: 412.211S; LOT: 4L80139 QUANTITY: 1); 5.0MM LOCKING SCREWS, WITH T25 STARDRIVE (PART: 412.210S LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR 1 BOLT FOR FEMORAL NECK SYSTEM 90MM LENGTH-STERILE. THIS IS REPORT 2 OF 5 FOR (B)(4).

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

  MAUDE report 12367654 ↗
• InjuryJul 29, 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 FOR A SURGICAL PROCEDURE WITH FEMORAL NECK SYSTEM(FNS). BUT THE PATIENT HAD ANOTHER FRACTURE RIGHT AT THE IMPLANT AND IT¿S REVISED TODAY, ON (B)(6) 2021. ALSO REMOVED THE FNS AND THEN INSERTED PROXIMAL FEMORAL NAILING SYSTEM(TFNA) TO APPLY AUGMENT CEMENT BUT BOTH BATCHES OF CEMENT WOULD NOT SPUR PROPERLY. IT WAS UNKNOWN THAT THE REVISION PROCEDURE COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) BOLT FOR FEMORAL NECK SYS 90 LENGTH-SILE. THIS REPORT IS 1 OF 4 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 12248234 ↗
• InjuryNov 20, 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 REVISION PROCEDURE DUE TO LOSS OF REDUCTION OF THE FEMORAL NECK SYSTEM (FNS). BEFORE THE REVISION PROCEDURE, THE PATIENT EXPERIENCED PAIN. INITIALLY, THE PATIENT WAS IMPLANTED WITH THE REPORTED DEVICE ON (B)(6) 2020. DURING THE REVISION PROCEDURE, THE DISTAL LOCKING SCREW HAD TO BE DRILLED OUT AS IT WAS CROSS THREADED WITH THE FNS PLATE. ALL THE FNS DEVICES WERE SUCCESSFULLY REMOVED THEN THE PATIENT WAS REVISED TO A TOTAL HIP ARTHROPLASTY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 20-MINUTE SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. (B)(4) WILL CAPTURE THE POST-OP EVENT WHERE THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO LOSS OF REDUCTION OF THE FEMORAL NECK SYSTEM (FNS), WHILE (B)(4) WILL CAPTURE THE INTRA-OP EVENT OF THE REVISION PROCEDURE WHERE THE DISTAL LOCKING SCREW HAD TO BE DRILLED OUT AS IT WAS CROSS THREADED INTO THE FNS PLATE. THIS REPORT IS FOR ONE (1) BOLT FOR FEMORAL NECK SYSTEM 85MM LENGTH-STERILE THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Code Available; Pain; Physical Asymmetry

  MAUDE report 10876171 ↗
• InjuryJan 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 REVISION SURGERY DUE TO DISPLACEMENT OF THE FEMORAL HEAD FROM THE NECK. INITIALLY THE PATIENT WAS IMPLANTED WITH THE REPORTED FEMORAL NECK SYSTEM (FNS) DEVICES ON (B)(6) 2019. DURING THE REVISION PROCEDURE ALL THE FNS DEVICES WERE SUCCESSFULLY REMOVED AND THE PATIENT WAS THEN REVISED TO HEMI ARTHROPLASTY LEFT HIP. THE 85MM BOLT WAS REMOVED DURING THE INITIAL SURGERY AND REPLACED WITH THE 90MM BOLT AS THE SURGEON FELT THAT THE 85MM BOLT WAS INITIALLY TOO SHORT. THE 90MM BOLT WAS THE ITEM REMOVED DURING THE REVISION SURGERY. THE PROCEDURE AS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. PATIENT STATUS WAS UNKNOWN. THIS REPORT IS FOR ONE (1) BOLT FOR FEMORAL NECK SYSTEM 90MM LENGTH-STERILE. THIS IS REPORT 3 OF 5 (B)(4). RELATED PRODUCT COMPLAINT : (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 9641234 ↗
• InjuryJan 15, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT A REMOVAL SURGERY DUE TO A FEMORAL NECK SYSTEM (FNS) CUT THROUGH TO THE FEMORAL HEAD. ORIGINALLY, THE PATIENT WAS IMPLANTED WITH THE FNS SYSTEM ON AN UNKNOWN DATE. THE FNS IMPLANTS WERE REMOVED AND A HEMIARTHROPLASTY WAS PERFORMED. THE SURGERY WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. CONCOMITANT DEVICES: FNS PLATE (PART#: 04.168.000S, LOT#: 5L62330, QUANTITY#: 1); TITANIUM (TI) LOCKING SCREW (PART#: 412.214S, LOT#: 3L25990, QUANTITY#: 1). THIS REPORT IS FOR ONE BOLT FOR FEMORAL NECK SYSTEM 90MM LENGTH-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9591511 ↗
• InjuryJan 15, 2020Migration or Expulsion of Device; Appropriate Device Problem Term/Code Not Available; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT A REMOVAL OF THE FEMORAL NECK SYSTEM (FNS) DEVICES DUE TO A CUT OUT. THE PATIENT WAS INITIALLY IMPLANTED WITH THE REPORTED DEVICES ON (B)(6) 2019. DURING THE PROCEDURE ALL OF THE FNS IMPLANTS WERE SUCCESSFULLY REMOVED AND PATIENT WAS THEN REVISED TO A HEMIARTHROPLASTY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. PATIENT STATUS WAS UNKNOWN. CONCOMITANT DEVICES: FNS PLATE (PART # 04.168.000S, LOT # 5L62330, QUANTITY 1), LOCKING SCREW (PART # 412.214S, LOT # 3L25990, QUANTITY 1). THIS REPORT IS FOR ONE BOLT FOR FEMORAL NECK SYSTEM 90MM LENGTH-STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9590870 ↗
• InjuryJul 16, 2019Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A HARDWARE REMOVAL DUE TO INFECTION AND IMPLANT CUT THROUGH THE FEMORAL HEAD. INITIALLY, THE PATIENT WAS IMPLANTED WITH FEMORAL NECK SYSTEM ABOUT 3-6 MONTHS AGO TO TREAT A SUBCAPITAL FEMORAL NECK FRACTURE. AS PER THE SURGEON, THE ANTIROTATION SCREW AND BARREL LENGTH MEASURED OUT TO BE THE SAME SIZE AS RECOMMENDED IN THE SURGICAL TECHNIQUE. THE PLATE ALSO HAD TWO (2) UNKNOWN UNICORTICAL LOCKING SCREWS THAT REMAINED INTACT. PATIENT OUTCOME AND SURGERY DELAY WERE UNKNOWN. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) NECK FIX BOLT L90 TAN. THIS REPORT IS 2 OF 4 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8796236 ↗
• 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 1 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 8667541 ↗
• InjuryJan 16, 2019Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2018 PATIENT HAD A FEMORAL NECK SYSTEM IMPLANTED FOR A FEMORAL NECK FRACTURE. THE PATIENT SUBSEQUENTLY HAD MULTIPLE FALLS POST-OPERATIVE WHICH RESULTED IN HIS FEMORAL HEAD ROTATING AND THE IMPLANT FOLLOWED. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 AND CONVERTED TO A TOTAL HIP. PATIENT AND SURGICAL OUTCOME WERE NOT REPORTED.

  Patient problems: No Code Available

  MAUDE report 8253313 ↗