NA 412.217SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982275448), received between Jan 16, 2019 and Mar 2, 2026 — classified as 5 injuries, 1 malfunction.

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. 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.

• 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 24481909 ↗
• InjuryFeb 23, 2023Break; Break

  THE PATIENT STATUS/OUTCOME WAS REPORTED TO BE GOOD.

  Patient problems: Failure of Implant

  MAUDE report 16432337 ↗
• 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 (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) 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 46MM-STERILE. THIS IS REPORT 5 OF 6 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 11572316 ↗
• MalfunctionMar 25, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT, ON (B)(6) 2021, THE PATIENT UNDERWENT A REVISION OF THE LONG TITANIUM TROCHANTERIC FIXATION NAIL (TFN). THE FEMORAL NECK SYSTEMS WERE IMPLANTED ABOUT A YEAR AND A HALF AGO. THEY WERE REMOVED AND REPLACED WITH LONG TFN¿S. ON THE LEFT SIDE, SHAFT SCREW WOULD NOT COME OUT, SO THE SURGEON HAD TO CUT THE PLATE JUST PROXIMAL TO THE SHAFT SCREW. RIGHT SIDE CAME OUT EASILY. THERE WAS NO SURGICAL DELAY AND PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 5.0 TI LCKNG SCR SLF-TPNG T25 SD 46-SILE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11570777 ↗
• 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 1 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 46MM-STERILE. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Code Available; Pain

  MAUDE report 10480437 ↗
• InjuryJan 16, 2019Migration; Migration

  ON (B)(6) 2018 THE PT HAD A FEMORAL NECK SYSTEM IMPLANTED FOR A FEMORAL NECK FRACTURE. THE PT SUBSEQUENTLY HAD MULTIPLE FALLS POST-OPERATIVE WHICH RESULTED IN HIS FEMORAL HEAD ROTATING AND THE IMPLANT FOLLOWED. THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 AND CONVERTED TO A TOTAL HIP. THIS REPORT IS FOR (1) 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 46MM-STERILE.THIS REPORT IS 3 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8253304 ↗