NA 412.219SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982275462), received between Aug 25, 2021 and Dec 1, 2021 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE REMOVAL SURGERY, THE SURGEON REMOVED THE FEMORAL NECK PLATE, ONE ANTIROTATION SCREW, ONE LOCKING SCREW, AND ONE BOLT. PATIENT WAS IN PAIN AND THE FEMORAL HEAD HAD AVN. PATIENT HAS DEMENTIA. EVERYTHING WAS REMOVED SUCCESSFULLY. THE SURGEON THEN CONVERTED THIS PATIENT TO A TOTAL ARTHROPLASTY. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) 5.0 TI LCKNG SCR SLF-TPNG T25 SD 50-SILE. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 12909594 ↗
• 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 50-SILE. THIS REPORT IS 2 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 12368393 ↗