NA 04.168.485SRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982274595), received between Sep 30, 2019 and Sep 27, 2022 — classified as 11 injuries, 1 malfunction.

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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) ANTIROTATION SCR FEM NECK 85 LNTH -S THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

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

  MAUDE report 15491643 ↗
• 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 3 OF 4 FOR (B)(4). THIS REPORT IS FOR A ANTIROTATION SCREW FOR FNS.

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

  MAUDE report 14025388 ↗
• 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) ANTIROTATION SCREW FOR FEMORAL NECK SYS 85MM LENGTH - STERIL. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12804929 ↗
• 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) ANTIROTATION SCREW FOR FEMORAL NECK SYS 85MM LENGTH - STERILE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12320832 ↗
• 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) ANTIROTATION SCR FEM NECK 85 LNTH -S. THIS REPORT IS 5 OF 5 FOR (B)(4).

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

  MAUDE report 12081275 ↗
• 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 ANTIROTATION SCREW FOR FEMORAL NECK SYS 85MM LENGTH - STERIL. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11727871 ↗
• 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) ANTIROTATION SCREW FOR FEMORAL NECK SYS 85MM LENGTH - STERIL. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Physical Asymmetry

  MAUDE report 11586170 ↗
• 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 3 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 10250400 ↗
• 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 10189913 ↗
• 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: BOLT FOR FEMORAL NECK SYSTEM 80MM LENGTH-STERILE (PART NUMBER 04.168.280S, LOT UNKNOWN, QUANTITY 1), FEMORAL NECK SYSTEM PLATE 1 HOLE ¿ STERILE (PART NUMBER 04.168.000S, 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) ANTI-ROTATION SCREW FOR FEMORAL NECK SYS 85MM LENGTH ¿ STERILE. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 9961937 ↗
• 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) ANTIROTATION SCREW FOR FEMORAL NECK SYS 85MM LENGTH - STERILE. THIS IS REPORT 5 OF 5 (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 9641236 ↗
• 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 DEVICE REPORTED: 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) ANTI-ROTATION SCREW FOR FEMORAL NECK SYS 85MM LENGTH - STERILE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 9135267 ↗