NA 412.212SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982275394), received between Jan 29, 2020 and Sep 27, 2022 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

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 6 most recent of 6 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)5.0 TI LCKNG SCR SLF-TPNG T25 SD 36-SILE. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

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

  MAUDE report 15491647 ↗
• 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) 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 36MM-STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12320811 ↗
• 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 4 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 10250442 ↗
• MalfunctionJun 29, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A REMOVAL PROCEDURE DUE TO AVASCULAR NECROSIS (AVN) OF THE FEMORAL HEAD ON (B)(6) 2020, THE SURGEON EXPERIENCED DIFFICULTY IN THE REMOVAL OF THE FEMORAL NECK SYSTEM (FNS) HARDWARE DUE TO THE LOCKING SCREW BEING COLD WELDED TO THE PLATE. INITIALLY, THE PATIENT HAD FNS IMPLANTATION ON (B)(6) 2020. IT WAS ALSO MENTIONED THAT THE REMOVAL TOOL WAS BENT DURING THE REMOVAL PROCESS. A BROKEN SCREW REMOVAL WAS USED TO REMOVE THE SCREW FROM PLATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 30 MINUTES SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. CONCOMITANT DEVICE REPORTED: FNS ANTIROTATION SCREW (PART # 04.168.495S, LOT # UNKNOWN, QUANTITY 1), FNS BOLT (PART # 04.168.295S, LOT # UNKNOWN, QUANTITY 1). THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10208081 ↗
• InjuryJun 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 REMOVAL OF THE FEMORAL NECK SYSTEM (FNS) DUE TO AVASCULAR NECROSIS (AVN). INITIALLY, THE PATIENT HAD FNS IMPLANTATION ON (B)(6) 2020. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 30 MINUTE SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS PRODUCT COMPLAINT, (B)(4), IS RELATED TO (B)(4). (B)(4) CAPTURES THE POST-OP EVENT WHERE THE PATIENT UNDERWENT A REMOVAL OF THE FEMORAL NECK SYSTEM (FNS) DUE TO AVASCULAR NECROSIS (AVN), WHILE (B)(4) WILL CAPTURE THE INTRA-OP EVENT WHERE THE SURGEON EXPERIENCED DIFFICULTY IN THE REMOVAL OF THE FEMORAL NECK SYSTEM (FNS) HARDWARE DUE TO THE LOCKING SCREW BEING COLD WELDED TO THE PLATE, A REMOVAL TOOL WAS ALSO BENT DURING THE REMOVAL PROCESS. CONCOMITANT DEVICES REPORTED: FEMORAL NECK SYSTEM PLATE 1 HOLE ¿ STERILE (PART NUMBER 04.168.000S, LOT UNKNOWN, QUANTITY 1), BOLT FOR FEMORAL NECK SYSTEM 95MM LENGTH-STERILE (PART NUMBER 04.168.295S, LOT UNKNOWN, QUANTITY 1), ANTIROTATION SCREW FOR FEMORAL NECK SYS 95MM LENGTH ¿ STERILE (PART NUMBER 04.168.495S, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES 1 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 36MM-STERILE. THIS IS REPORT 4

  Patient problems: Necrosis; No Code Available

  MAUDE report 10206482 ↗
• 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) 5.0 MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 36MM-STERILE. THIS IS REPORT 4 OF 5 (B)(4). RELATED PRODUCT COMPLAINT : (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 9641233 ↗