NA 04.168.285SRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886982274731), received between Sep 30, 2019 and Sep 25, 2023 — classified as 11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2023Use of Device Problem; Difficult to Advance; Use of Device Problem; Difficult to Advance

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF SURGERY FOR PROXIMAL FEMUR FRACTURE WITH THE BOLT IN QUESTION. THE FEMORAL HEAD WAS REAMED TO 85 MM AS MEASURED AND THE SURGEON DRILLED TO ABOUT 5MM IN FRONT OF THE TIP OF THE FEMORAL HEAD. WHEN THE 85MM BOLT WAS INSERTED, IT STOPPED SLIGHTLY TOWARD THE FRONT. THE SURGEON USED A CYLINDER TO HAMMER IT, BUT THE INSERTION POSITION OF THE BOLT DID NOT CHANGE. THE SURGEON GUESSED THAT BECAUSE THE CERVICAL BODY ANGLE WAS ABOUT 135 TO 140 DEGREES, THE TIP OF THE PLATE CONTACTED THE BONE FIRST, CAUSING THE BOLT TO STOP EARLIER THAN EXPECTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY, NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A BOLT FOR FEMORAL NECK SYSTEM 85MM LENGTH-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17808248 ↗
• InjuryAug 13, 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 REVISION SURGERY FOR REMOVAL OF FEMORAL NECK SYSTEM (FNS) IMPLANTS DUE TO PAIN. THE DATE OF THE ORIGINAL SURGERY WAS (B)(6) 2020. THERE WAS NO BROKEN HARDWARE. ALL IMPLANTS WERE SUCCESSFULLY REMOVED WITHOUT COMPLICATION. THIS REPORT IS FOR ONE (1) BOLT FOR FEMORAL NECK SYSTEM 85MM LENGTH-STERILE. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12320915 ↗
• InjuryJun 28, 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 HARDWARE REMOVAL DUE TO PATIENT BROKE HER FEMUR BELOW THE HARDWARE THAT WAS IN. THE FEMORAL NECK SYSTEM (FNS) IMPLANTS WERE REMOVED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES (5) DEVICES. THIS REPORT IS FOR (1) BOLT FOR FEMORAL NECK SYS 85 LENGTH-SILE. THIS REPORT IS 4 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 12081198 ↗
• InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT REMOVAL OF THE FEMORAL NECK SYSTEM IMPLANT DUE TO NONUNION. ALL IMPLANTS WERE INTACT, NOT BROKEN. A TOTAL HIP ARTHROPLASTY WAS IMPLANTED ON (B)(6) 2021 TO ADDRESS THE NON-UNION. THIS REPORT IS FOR 1 BOLT FOR FEMORAL NECK SYSTEM 85MM LENGTH-STERILE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11727665 ↗
• InjuryMar 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 THE PATIENT UNDERWENT HARDWARE REMOVAL DUE TO COLLAPSED FEMORAL NECK. THE PATIENT FELL WHICH CAUSED THE FEMORAL NECK TO COLLAPSE. THE IMPLANTS DID NOT FAIL OR BROKE, BUT THEY COLLAPSED SIGNIFICANTLY ALONG WITH THE FEMORAL NECK REQUIRING A CONVERSION. THE SURGEON REMOVED A FEMORAL NECK SYSTEM (FNS) AND CONVERTED TO A TOTAL HIP ARTHROPLASTY. REVISION SURGERY WAS COMPLETED SUCCESSFULLY AND THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) BOLT FOR FEMORAL NECK SYSTEM 85MM LENGTH-STERILE. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Physical Asymmetry

  MAUDE report 11585953 ↗
• 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 85 LENGTH-SILE. THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 11572324 ↗
• InjuryJan 26, 2021Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING HIP SURGERY, THE BOLT FOR FEMORAL NECK SYSTEM (FNS) FAILED. IT WAS MENTIONED THAT THE IMPLANT WAS STILL IN THE EARLY STAGES OF ITS LIFE. THE PRE-OP FIXATION WASN¿T VALGUS IMPACTED AND ALREADY HIGH DEGREE OF STRESS ACROSS SUB CAP BORDER. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN LOCKING SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). UNKNOWN ANTIROTATION SCREW FNS (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). UNKNOWN PLATE FNS (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT INVOLVES ONE (1)BOLT FOR FEMORAL NECK SYSTEM 85MM LENGTH-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 11231267 ↗
• InjuryJul 9, 2020Adverse 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 ADDITIONAL FRACTURES OCCURRED POST-OPERATIVELY AND WERE CONFIRMED BY X-RAY FOR A FEMORAL NECK SYSTEM (FNS). REVISION SURGERY OCCURRED ON (B)(6) 2020, IN WHICH THE FNS IMPLANTS WERE REMOVED AND THE PATIENT REVISED TO A BIPOLAR HIP ARTHROPLASTY (BHA). THE ORIGINAL OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR FEMORAL NECK FRACTURES USING THE FNS SYSTEM OCCURRED (B)(6) 2020. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 10250352 ↗
• InjuryJun 24, 2020Migration; Migration

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO A TOTAL JOINT.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 10189861 ↗
• InjuryMar 30, 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 A FEMORAL NECK SYSTEM (FNS) IMPLANT DUE TO NONUNION AND WAS CONVERTED INTO A TOTAL HIP. THE PATIENT WAS INITIALLY IMPLANTED WITH THE FOLLOWING FEMORAL NECK SYSTEM IMPLANTS, ONE BOLT FOR FEMORAL NECK SYSTEM, ONE FEMORAL NECK SYSTEM PLATE, ONE 85MM UNKNOWN ANTIROTATION BOLT, AND TWO 5.0MM UNKNOWN TITANIUM LOCKING SCREW ON AN UNKNOWN DATE. THE HARDWARE DID NOT FAIL, IT REMAINED IN ITS POSITION. THE PATIENT'S BONE QUALITY WAS EXTREMELY POOR. THE DEVICES WERE REMOVED. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY COMPLETED. PATIENT STATUS WAS UNKNOWN. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 9896845 ↗
• MalfunctionJan 30, 2020Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A DISPLACED FEMORAL HEAD FIXING PROCEDURE ON (B)(6) 2019, THE 85MM FNS BOLT WAS REMOVED SHORTLY AFTER IT WAS IMPLANTED. THE SURGEON FELT THAT THE REPORTED BOLT WAS INITIALLY TOO SHORT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF 90MM FNS BOLT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: FNS PLATE (PART # 04.168.000S-US, LOT # 3L31912, QUANTITY 1), ANTIROTATION SCREW (PART # 04.168.485S, LOT # 3L12978, QUANTITY 1), LOCKING SCREW (PART # 412.212S, LOT # 2L56179, QUANTITY 1). THIS IS REPORT 01 OF 01 OF (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9647962 ↗
• 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 85MM LENGTH-STERILE. THIS IS REPORT 2 OF 5 (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 9641235 ↗
• InjurySep 30, 2019Break; Break

  IT WAS REPORTED ON (B)(6) 2019, THE PATIENT PRESENTED IN THE CLINIC DUE TO POST-OPERATIVE PAIN ON THE HIP. AN X-RAY SHOWED NON-UNION WITH BROKEN ANTI-ROTATION SCREW AND POTENTIALLY THE BOLT IS BROKEN. THE DISTAL LOCKING SCREWS AND PLATE APPEAR TO BE INTACT. INITIALLY, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE RIGHT FEMUR ON AN UNKNOWN DATE. AT THIS POINT, NO REVISION SURGERY HAS BEEN SCHEDULED. CONCOMITANT MEDICAL PRODUCTS: TITANIUM LOCKING COMPRESSION PLATE (LCP) PROXIMAL LATERAL TIBIA (PART # 422.226, LOT # 2192572, QUANTITY 1). FEMORAL NECK SYSTEM PLATE (PART # 04.168.000S, LOT # UNKNOWN, QUANTITY 1). TITANIUM LOCKING SCREW (PART # 412.213S, LOT # UNKNOWN, QUANTITY 1) AND UNKNOWN LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) BOLT FOR FEMORAL NECK SYSTEM 85MM LENGTH-STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 9135294 ↗