NA 04.168.490SRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982274601), received between Jan 16, 2019 and Jul 3, 2023 — classified as 10 injuries.

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

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Fall; Limb Fracture

  MAUDE report 17249637 ↗
• 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 ONE (1) ANTIROTATION SCR FEM NECK 90 LNTH -S. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 13213235 ↗
• 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) ANTIROTATION SCREW FOR FEMORAL NECK SYS 90MM LENGTH - STERIL. THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

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

  MAUDE report 12367697 ↗
• 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) ANTIROTATION SCR FEM NECK 90 LNTH -S. THIS REPORT IS 2 OF 4 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 12248258 ↗
• InjuryDec 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE FEMORAL NECK SYSTEM IMPLANT HAD TO BE REMOVED DUE TO THE SURGEON CONVERTING TO A TOTAL HIP REPLACEMENT. THE ORIGINAL IMPLANTATION WAS UNKNOWN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY REPORTED. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. CONCOMITANT DEVICES REPORTED: FEMORAL NECK SYSTEM PLATE 1 HOLE ¿ STERILE (PART NUMBER 04.168.000S, LOT UNKNOWN, QUANTITY 1); BOLT FOR FEMORAL NECK SYSTEM 100MM LENGTH-STERILE (PART NUMBER 04.168.300S, LOT UNKNOWN, QUANTITY 1); 5.0MM TI LOCKING SCR SLF-TPNG WITH T25 STARDRIVE RECESS 36MM (PART NUMBER 412.212, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) ANTIROTATION SCREW FOR FEMORAL NECK SYS 90MM LENGTH ¿ STERILE. THIS IS REPORT 3 OF 4 FOR (B)(4).

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

  MAUDE report 11102020 ↗
• 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) ANTI-ROTATION SCREW FOR FEMORAL NECK SYS 85MM LENGTH - STERILE. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Code Available; Pain; Physical Asymmetry

  MAUDE report 10876153 ↗
• InjuryOct 13, 2020Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, PATIENT UNDERWENT REMOVAL OF A BROKEN ANTIROTATION SCREW FOR FEMORAL NECK SYSTEM (FNS). ALL OTHER IMPLANTS DID NOT MALFUNCTION. IMPLANT DATE WAS SOMETIME IN (B)(6) 2020. THERE WAS NO SURGICAL DELAY. THE REMOVAL WAS COMPLETED. PATIENT DID NOT HEAL PROPERLY. CONCOMITANT DEVICES REPORTED: UNKNOWN LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1); FN PLATE (PART# 04.168.000, LOT# 5L77162, QUANTITY 1); FNS BOLT (PART# 04.168.290, LOT# 31P8658, QUANTITY 1). THIS REPORT IS FOR ONE (1) ANTIROTATION SCREW FOR FEMORAL NECK SYS 90MM LENGTH.

  Patient problems: Failure of Implant; Injury; No Code Available

  MAUDE report 10673042 ↗
• 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 ANTIROTATION SCREW FOR FEMORAL NECK SYS 90MM LENGTH - STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9591541 ↗
• 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 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 ANTIROTATION SCREW FOR FEMORAL NECK SYS 90MM LENGTH - STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 9590916 ↗
• 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 8253305 ↗