NA 412.218SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982275455), received between Apr 17, 2020 and Aug 25, 2021 — classified as 4 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 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, PATIENT UNDERWENT A HARDWARE REMOVAL AND REVISION SURGERY DUE TO PERIPROSTHETIC FRACTURE. PATIENT WAS TREATED WITH A FEMORAL NECK SYSTEM ON (B)(6) 2021 COMPLAINED OF CONTINUED PAIN POSTOPERATIVELY. A CT SCAN REVEALED A FRACTURE DISTAL TO THE PLATE OF THE FNS. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM ON (B)(6) 2021; THE FNS HARDWARE WAS REMOVED AND LONG TROCHANTERIC FIXATION NAIL, HELICAL BLADE, AND LOCKING SCREW WERE INSERTED. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES FIVE(5) DEVICES. THIS REPORT IS FOR (1) 5.0 TI LCKNG SCR SLF-TPNG T25 SD 48-SILE. THIS REPORT IS 1 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 12368388 ↗
• 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 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 48MM-STERILE. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11727812 ↗
• 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 10189940 ↗
• InjuryApr 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON MARCH 25, 2020, THE SURGEON REPORTED A PATIENT WITH A NEW FRACTURE NEAR A PLATE FROM THE FEMORAL NECK SYSTEM (FNS) CONSTRUCT. THE INITIAL SURGERY WAS CONDUCTED ON (B)(6) 2020 AND WAS SUCCESSFULLY COMPLETED. THE FNS CONSTRUCT APPEARS TO BE INTACT WITHOUT WRAPPING OR ANY IMPLANT FRAGMENTATION. ORIGINALLY THE IMPLANTED DEVICES WERE: TWO (2) TITANIUM LOCKING SCREW, ONE (1) FEMORAL NECK SYSTEM PLATE, ONE (1) BOLT, AND ONE (1) ANTI ROTATION SCREWS. IT WAS UNKNOWN IF THERE WAS A REVISION OR HARDWARE REMOVAL. PATIENT STATUS WAS UNKNOWN. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 9971641 ↗