NA 04.168.280SRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886982274724), received between Oct 31, 2019 and Mar 11, 2026 — classified as 12 injuries, 2 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON OPENED A STERILE BOXED FNS BOLT AND IT WOULD NOT THREAD ONTO THE INSERTION HANDLE. AFTER MINUTES OF TRYING, THE SURGEON HAD TO OPEN AN ADDITIONAL STERILE BOXED BOLT THAT DID ATTACH TO THE INSERTION HANDLE. THERE WAS FIFTEEN MINUTES SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24568727 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH FNS IMPLANTS. AFTER THE SURGERY, OSTEONECROSIS OF THE FEMORAL HEAD OCCURRED, AND THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2025. (B)(4) IS RELATED TO (B)(4) WHICH REPORTS THE BREAKAGE OF THE JJ PRODUCT OCCURRED AT THE REVISION SURGERY, AND (B)(4) WHICH REPORTS THE BREAKAGE OF THE POLO PRODUCT OCCURRED AT THE REVISION SURGERY.

  Patient problems: Necrosis

  MAUDE report 22545916 ↗
• InjurySep 27, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022 THE REVISION OF FEMORAL NECK SYSTEM DUE TO CUT THROUGH. THE SURGERY WAS COMPLETED WITHOUT A SURGICAL DELAY. SOME FRAGMENTS WAS GENERATED. PATIENT STATUS/ OUTCOME: UNKNOWN THIS REPORT IS FOR ONE (1)BOLT FOR FEMORAL NECK SYS 80 LENGTH-SILE. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant

  MAUDE report 15491671 ↗
• InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT ORIF SURGERY FOR A FEMORAL NECK FRACTURE WITH FNS IMPLANTS. AFTER SURGERY ON (B)(6) 2022, THE PATIENT COMPLAINED OF PAIN, AND SUBTROCHANTERIC FRACTURE OF FEMUR AT THE AREA WHERE THE LOCKING SCREW OF FNS WAS INSERTED WAS CONFIRMED. ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED. IN THE REVISION SURGERY, FNS IMPLANTS WERE REMOVED AND REPLACED WITH FEMORAL RECON NAIL IMPLANTS TO FIX THE FRACTURE SITE. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A BOLT FOR FEMORAL NECK SYSTEM 80MM LENGTH-STERILE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 15364587 ↗
• InjuryApr 6, 2022Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION WITH THE FNS FOR A MEDIAL FRACTURE OF THE FEMORAL NECK. THE PATIENT FELL SEVERAL WEEKS AFTER THE SURGERY AND WAS UNDER OBSERVATION. MIGRATION/CUT-OUT WAS CONFIRMED ON (B)(6) 2022. THE REVISION SURGERY FOR REMOVAL OF THE FNS AND THE BIPOLAR HIP ARTHROPLASTY WILL BE PERFORMED ON (B)(6) 2022. ALTHOUGH THE FRACTURE WAS OUTSIDE THE SCOPE OF THE OSTEOSYNTHESIS, THE SURGEON DECIDED TO PERFORM THE OPEN REDUCTION INTERNAL FIXATION WITH THE FEMORAL NECK SYSTEM (FNS) TO REDUCE BLEEDING BECAUSE OF THE UNDERLYING DISEASE. THIS EVENT MIGHT HAVE BEEN CAUSED BY THE FALL. REVISION SURGERY WAS DONE ON (B)(6) 2022. FNS IMPLANTS IN QUESTION WERE REMOVED AND REPLACED WITH BHA. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH 1 HOUR DELAY. THE DELAY IN SURGERY IS DUE TO INSTRUMENT BREAKAGE OF OTHER COMPANIES' PRODUCTS. NO FURTHER INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 4 FOR (B)(4). THIS REPORT IS FOR A BOLT FOR FNS.

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

  MAUDE report 14025422 ↗
• MalfunctionNov 12, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A FEMORAL NECK SYSTEM (FNS) PROCEDURE, WHEN PLACING THE ANTI-ROTATION SCREW, THE ANTI-ROTATION SCREW WOULD NOT LOCK INTO THE BOLT. THE ANTI-ROTATION SCREW, BOLT, AND SIDE PLATE WERE REMOVED, NEW IMPLANTS IMPLANTED AND THE CASE FINISHED SUCCESSFULLY WITHOUT FURTHER ISSUE. THERE WAS A FIVE (5) MINUTES SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) BOLT FOR FEMORAL NECK SYSTEM 80MM LENGTH-STERILE. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12804957 ↗
• InjuryOct 8, 2021Break; Break

  IT WAS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL OF FEMORAL NECK SYSTEM (FNS) DUE TO NONUNION AND PATIENT SUSTAINED A FALL. THERE WAS A IMPLANT BREAKAGE. IT TOOK APPROXIMATELY (40) MINUTES TO GET THE HARDWARE OUT. EVENTUALLY EVERYTHING WAS REMOVED SUCCESSFULLY. THE PATIENT IS DOING WELL AT THIS POINT. THIS REPORT IS FOR (1) BOLT FOR FEMORAL NECK SYSTEM 80MM LENGTH-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12601403 ↗
• InjuryJun 3, 2021Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY OF THE FEMORAL NECK SYSTEM DUE TO CUT OUT ON (B)(6) 2021. CONVERTING TO A HEMIARTHROPLASTY. PROCEDURE OUTCOME WAS UNKNOWN, AND PATIENT HAS CONSEQUENCES. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) BOLT FOR FEMORAL NECK SYS 80 LENGTH-SILE THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11932244 ↗
• InjuryMar 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, THE PATIENT UNDERWENT A REVISION TO LONG TITANIUM TROCHANTERIC FIXATION NAIL (TFN). THE SURGEON REMOVED BILATERAL FEMORAL NECK SYSTEMS DUE TO STRESS RISERS AT THE LEVEL OF THE SHAFT SCREW. THE FEMORAL NECK SYSTEMS WERE IMPLANTED ABOUT A YEAR AND HALF AGO, AND THEY WERE REMOVED AND REPLACED WITH LONG TFN¿S. ON THE LEFT SIDE, THE SHAFT SCREW WOULD NOT COME OUT, SO THE SURGEON HAD TO CUT THE PLATE JUST PROXIMAL TO THE SHAFT SCREW. THE RIGHT SIDE CAME OUT EASILY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT CAPTURES THE POST-OP EVENT OF REVISION DUE TO STRESS RISERS AT THE LEVEL OF THE SHAFT SCREW, WHILE RELATED COMPLAINT (B)(4) REPORTS THE INTRA-OP EVENT OF THE SHAFT SCREW THAT WOULD NOT COME OUT, SO THE SURGEON HAD TO CUT THE PLATE. THIS REPORT IS FOR ONE (1) BOLT FOR FEMORAL NECK SYS 80 LENGTH-SILE. THIS IS REPORT 2 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 11572292 ↗
• InjuryMar 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT HIP REVISION SURGERY DUE TO MALUNION AND FEMORAL NECK COLLAPSE. THE SURGEON REMOVED ONE (1) FEMORAL NECK SYSTEM PLATE, ONE (1) FEMORAL NECK BOLT, ONE (1) ANTIROTATION FEMORAL NECK SCREW, AND ONE (1) 5MM TI LOCKING SCREW. THE ORIGINAL PROCEDURE DATE IS UNKNOWN. THE HARDWARE WAS REMOVED WITH NO ISSUES. THE PATIENT WAS THEN IMPLANTED WITH A HIP HEMI ARTHROPLASTY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) BOLT FOR FEMORAL NECK SYSTEM 80MM LENGTH-STERILE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Malunion of Bone

  MAUDE report 11438925 ↗
• InjuryJan 8, 2021Adverse 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 AND REVISION PROCEDURE OF THE FEMORAL NECK SYSTEM (FNS) DEVICES DUE TO A BREAK BELOW THE FNS PLATE SECONDARY TO FALL. INITIALLY, THE PATIENT WAS IMPLANTED WITH THE ORIGINAL DEVICES ON (B)(6) 2020. IT WAS MENTIONED THAT THERE WAS NO HARDWARE THAT WAS BROKEN, JUST THE BONE AROUND IT. DURING THE REVISION PROCEDURE, THE FNS IMPLANTS WERE REMOVED AND THE PATIENT WAS REVISED TO A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) BOLT FOR FEMORAL NECK SYSTEM 80MM LENGTH-STERILE. THIS REPORT IS 3 OF 4 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 11142461 ↗
• InjuryApr 15, 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 OF FEMORAL NECK SYSTEM (FNS) IMPLANTS TO HEMIARTHROPLASTY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: FEMORAL NECK SYSTEM PLATE 1 HOLE ¿ STERILE (PART NUMBER 04.168.000S, LOT UNKNOWN, QUANTITY 1), ANTI-ROTATION SCREW FOR FEMORAL NECK SYS 85MM LENGTH ¿ STERILE (PART NUMBER 04.168.485S, LOT UNKNOWN, QUANTITY 1), 5.0MM TI LOCKING SCR SLF-TPNG WITH T25 STARDRIVE RECESS 42MM (PART NUMBER 412.215, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) BOLT FOR FEMORAL NECK SYSTEM 80MM LENGTH-STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 9961864 ↗
• InjuryDec 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION SURGERY FOR THE RIGHT FEMORAL NECK FRACTURE WITH FEMORAL NECK SYSTEM (FNS). WHILE DRILLING THE LOCKING SCREW THE SURGEON DRILLED THROUGH THE ¿2 HOLE PLATE¿ OF THE INSERTION HANDLE IN ERROR. HE DRILLED THEN THROUGH THE ¿1 HOLE PLATE¿ OF THE INSERTION HANDLE AND INSERTED A LOCKING SCREW. THE SURGERY WAS DELAYED BY LESS THAN 30 MINUTES. ON (B)(6) 2019, THE HOSPITAL REPORTED THAT THE PATIENT GOT A SUBTROCHANTERIC FRACTURE ON THE MISTAKENLY DRILLED POSITION. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2019 TO REMOVE THE FNS AND REDUCE THE SUBTROCHANTERIC FRACTURE WITH A NESPLON CABLE. THE SURGEON FIXED THE FRACTURE WITH A LONG NAIL, (ZIMMER BIOMET PRODUCT). THIS REPORT IS FOR ONE (1) BOLT FOR FEMORAL NECK SYSTEM 80 MM LENGTH-STERILE. (B)(4).

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

  MAUDE report 9444738 ↗
• InjuryOct 31, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED ON AN UNKNOWN DATE, AN UNKNOWN ORTHOPEDIC PROCEDURE WITH FEMORAL NECK SYSTEM (FNS) WAS PERFORMED BUT LATER IT WAS FOUND OUT TO HAVE CUT OUT. IT IS UNKNOWN HOW THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WAS PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9263375 ↗