NA 412.213SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982275400), received between Jul 24, 2019 and Sep 6, 2022 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT ORIF SURGERY FOR A FEMORAL NECK FRACTURE WITH FNS IMPLANTS. AFTER SURGERY ON (B)(6) 2022, THE PATIENT COMPLAINED OF PAIN, AND SUBTROCHANTERIC FRACTURE OF FEMUR AT THE AREA WHERE THE LOCKING SCREW OF FNS WAS INSERTED WAS CONFIRMED. ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED. IN THE REVISION SURGERY, FNS IMPLANTS WERE REMOVED AND REPLACED WITH FEMORAL RECON NAIL IMPLANTS TO FIX THE FRACTURE SITE. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 38MM-STERILE. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 15364625 ↗
• InjuryJul 29, 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 FOR A SURGICAL PROCEDURE WITH FEMORAL NECK SYSTEM(FNS). BUT THE PATIENT HAD ANOTHER FRACTURE RIGHT AT THE IMPLANT AND IT¿S REVISED TODAY, ON (B)(6) 2021. ALSO REMOVED THE FNS AND THEN INSERTED PROXIMAL FEMORAL NAILING SYSTEM(TFNA) TO APPLY AUGMENT CEMENT BUT BOTH BATCHES OF CEMENT WOULD NOT SPUR PROPERLY. IT WAS UNKNOWN THAT THE REVISION PROCEDURE COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) 5.0 TI LCKNG SCR SLF-TPNG T25 SD 38-SILE. THIS REPORT IS 3 OF 4 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 12248246 ↗
• InjuryJun 28, 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 HARDWARE REMOVAL DUE TO PATIENT BROKE HER FEMUR BELOW THE HARDWARE THAT WAS IN. THE FEMORAL NECK SYSTEM (FNS) IMPLANTS WERE REMOVED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES (5) DEVICES. THIS REPORT IS FOR (1) 5.0 TI LCKNG SCR SLF-TPNG T25 SD 38-SILE THIS REPORT IS 2 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 12081202 ↗
• InjuryMar 8, 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 HIP REVISION SURGERY DUE TO MALUNION AND FEMORAL NECK COLLAPSE. THE SURGEON REMOVED ONE (1) FEMORAL NECK SYSTEM PLATE, ONE (1) FEMORAL NECK BOLT, ONE (1) ANTIROTATION FEMORAL NECK SCREW, AND ONE (1) 5MM TI LOCKING SCREW. THE ORIGINAL PROCEDURE DATE IS UNKNOWN. THE HARDWARE WAS REMOVED WITH NO ISSUES. THE PATIENT WAS THEN IMPLANTED WITH A HIP HEMI ARTHROPLASTY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 38MM-STERILE. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Malunion of Bone

  MAUDE report 11438964 ↗
• InjuryFeb 24, 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 THE REMOVAL OF AN UNKNOWN FEMORAL NECK SYSTEM (FNS) PLATE, TITANIUM LOCKING SCREW SELF-TAPPING, ANTIROTATION SCREW FOR FNS AND BOLT FOR FNS DUE TO NONUNION. IT WAS ORIGINALLY IMPLANTED ON (B)(6) 2019. ALL THE IMPLANTS ARE REMOVED SUCCESSFULLY. PATIENT STATUS WAS UNKNOWN. THIS REPORT IS FOR ONE 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 38MM-STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9744421 ↗
• InjuryJul 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY DUE TO A SUBTROCHANTERIC FRACTURE SUBSEQUENT TO THEIR INITIAL FRACTURE. THE PATIENT¿S ORIGINAL INJURY HAD NOT HEALED, AND A SECOND FRACTURE OCCURRED IN THE FEMUR, JUST DISTAL TO THE SIDE PLATE. THE SURGEON REMOVED ALL IMPLANTS; FEMORAL NECK SYSTEM PLATE, ANTIROTATION SCREW, FEMORAL NECK BOLT, 40MM TITANIUM LOCKING SCREW AND 30MM TITANIUM LOCKING SCREW. PATIENT WAS REVISED WITH A NON-SYNTHES GAMMA NAIL. ORIGINALLY, THE PATIENT WAS TREATED FOR A FEMORAL NECK FRACTURE ON (B)(6) 2019. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 5.0MM TITANIUM (TI) LOCKING SCREW 38MM. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s); Impaired Healing; No Code Available

  MAUDE report 8823563 ↗