NA 04.168.520SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982274663), received between Jun 13, 2024 and Jun 13, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 13, 2024Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY FOR REPAIR OF FEMORAL NECK FRACTURE WITH FEMORAL NECK SYSTEM ON (B)(6) 2024. ON (B)(6) 2024 THE PATIENT PRESENTED WITH HIP PAIN; X-RAY IMAGES CONFIRMED THAT THE FNS ANTI ROTATION SCREW HAD DISENGAGED FROM ITS POSITION RELATIVE TO THE FNS BOLT. THE FNS ANTI ROTATION SCREW HAD SUBSEQUENTLY COLLAPSED INDEPENDENTLY OF THE FNS BOLT. AS A RESULT, THE FNS BOLT WAS UNABLE TO COLLAPSE AS INTENDED AND THE FNS BOLT PENETRATED THE FEMORAL HEAD. PATIENT EXPERIENCED PAIN AND REDUCED MOBILITY. THE PATIENT UNDERWENT SURGERY FOR REMOVAL OF FNS IMPLANTS AND REVISION TO HEMIARTHROPLASTY ON (B)(6) 2024. ALL FNS COMPONENTS WERE REMOVED WITHOUT ANY ISSUE AND THE HEMIARTHROPLASTY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) ANTIROTATION SCREW FOR FEMORAL NECK SYS 120MM LENGTH - STER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 19529497 ↗