NA 04.168.300SRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982274762), received between Sep 1, 2020 and Mar 2, 2026 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (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. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION OF THE RIGHT FEMORAL NECK FRACTURE WITH RECTUS TENOTOMY AND TRANSFER DUE TO MOTORCYCLE ACCIDENT. PATIENT REPORTED ON (B)(6) 2026, THAT HE EXPERIENCED CHRONIC RIGHT HIP PAIN. HE IS AWARE OF BROKEN HARDWARE IN HIS RIGHT HIP AND DESIRES TO HAVE THE HARDWARE REMOVED.

  Patient problems: Pain

  MAUDE report 24482059 ↗
• InjuryJul 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A PATIENT UNDERWENT A REMOVAL OF FEMORAL NECK SYSTEM (FNS) DUE TO SECONDARY FRACTURE POST-OPERATIVE. PATIENT'S FEMUR WAS REVISED TO TROCHANTERIC FIXATION NAIL ADVANCED (TFNA). NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) BOLT FOR FEMORAL NECK SYSTEM 100MM LENGTH-STERILE THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 19812539 ↗
• InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED AN IMPLANT FAILURE OCCURRED POST OPERATIVELY ON AN UNKNOWN DATE. IMPLANT DATE IS UNKNOWN. PATIENT HAD REVISION SURGERY TO CONVERT TO TOTAL HIP ON (B)(6). 2023. THIS REPORT IS FOR BOLT FOR FEMORAL NECK SYS 100 LENGTH-S FOR (B)(4). THIS PC IS LINKED TO THE INTRAOPERATIVE REVISION EVENTS OCCURRING IN (B)(4).

  Patient problems: Insufficient Information; Physical Asymmetry

  MAUDE report 18170871 ↗
• MalfunctionJun 23, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2022, THE THREE INTERLOCKING PARTS OF THE FEMORAL NECK SYSTEM BROKE APART FROM EACH OTHER WHEN THEY WERE IMPLANTED. THIS REPORT IS FOR A BOLT FOR FEMORAL NECK SYSTEM 100MM LENGTH-STERILE. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14787098 ↗
• MalfunctionMay 25, 2022No Apparent Adverse Event; No Apparent Adverse Event

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NETHERLANDS AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PROCEDURE WAS AN IMPLANTATION OF AN FNS. DRILLING THE LOCKING HOLE FOR INSERTING THE 5.0 LOCKING SCREW, THE DRILL GOT STUCK IN THE PROTECTION SLEEVE, FOR THE FEMORAL NECK SYSTEM INSERTION INSTRUMENTS. THE DOCTOR COULD NOT MOVE THE DRILL IN ANY WAY. THE FNS WAS TAKEN OUT OF THE PATIENT AND AN DHS WAS INSERTED. THIS REPORT INVOLVES ONE (1) BOLT FOR FEMORAL NECK SYSTEM 100MM LENGTH-STERILE. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14498237 ↗
• InjuryMay 12, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT REMOVAL OF A FEMORAL NECK SYSTEM AND CONVERSION TO TOTAL HIP ARTHROPLASTY DUE TO THE IMPLANT WAS SUBSEQUENTLY BEGINNING TO CUT OUT. THE PATIENT WAS PREVIOUSLY TREATED FOR A FEMORAL NECK FRACTURE WITH THE FEMORAL NECK SYSTEM ON (B)(6) 2020. THE ANTI-ROTATION SCREW AND BOLT OF THE FNS SYSTEM WERE OBSERVED TO BE CUTTING OUT SUPERIORLY AS THE FEMORAL HEAD COLLAPSED INTO VARUS. THIS REPORT IS FOR ONE BOLT FOR FEMORAL NECK SYS 100 LENGTH-S. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 14371215 ↗
• 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 ONE (1) BOLT FOR FEMORAL NECK SYSTEM 100MM LENGTH-STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).

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

  MAUDE report 11886739 ↗
• 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); ANTIROTATION SCREW FOR FEMORAL NECK SYS 90MM LENGTH ¿ STERILE (PART NUMBER 04.168.490S, 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) BOLT FOR FEMORAL NECK SYSTEM 100MM LENGTH-STERILE. THIS IS REPORT 2 OF 4 FOR (B)(4).

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

  MAUDE report 11102019 ↗
• InjurySep 1, 2020Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT PRESENTED WITH HIP PAIN THREE WEEKS POST-OPERATIVE. ON X-RAY, IMPLANTS SHOW A SUPERIOR CUTOUT OF THE FEMORAL HEAD. THE ORIGINAL DATE OF IMPLANTATION WAS (B)(6) 2020. THE PATIENT WAS HAVING HER FEMORAL NECK SYSTEM (FNS) IMPLANTS REMOVED AND UNDERGOING A HIP HEMI ARTHROPLASTY. THE PROCEDURE AND PATIENT OUTCOMES WERE UNKNOWN. CONCOMITANT DEVICES REPORTED: ANTIROTATION SCREW FOR FEMORAL NECK SYS 100MM LENGTH - STER (PART# 04.168.500S, LOT# 3L32061, QUANTITY# 1); 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 46MM-STERILE (PART# 412.217S, LOT# 2L48457, QUANTITY# 1); BOLT FOR FEMORAL NECK SYSTEM 100MM LENGTH-STERILE (PART# 04.168.300S, LOT# 3L31939, QUANTITY# 1). THIS REPORT IS FOR ONE (1) NECK FIX BOLT L100 TAN. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10480435 ↗