NA 04.168.305SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982274779), received between Dec 1, 2021 and Jun 15, 2023 — classified as 1 death, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2021. PATIENT HISTORY FOLLOWS: ON OR ABOUT (B)(6) 2020, THE PATIENT SUFFERED A FALL AT HOME. X-RAY REPORTED A RIGHT INTERTROCHANTERIC FRACTURE AND A CT WHICH IDENTIFIED AN IMPACTED COMMINUTED RIGHT INTERTROCHANTERIC FRACTURE. ON (B)(6)2020 THE PATIENT UNDERWENT OPEN TREATMENT OF THE RIGHT FEMORAL NECK FRACTURE WITH A FEMORAL NECK SYSTEM (FNS) SCREW AND SIDE PLATE. ON (B)(6)2021, THE PATIENT COMPLAINED OF WORSENING RIGHT HIP PAIN AND LOWER EXTREMITY EDEMA. ON (B)(6) 2021, PATIENT REITERATED WORSENING PAIN AND HAD TO AMBULATE WITH A WALKER. FROM (B)(6)2021, PATIENT WAS HOSPITALIZED WITH CONSTANT RIGHT HIP PAIN. PATIENT STATED THEY HAD SUFFERED NO FALLS OR INJURIES SINCE INITIAL SURGERY. STAFF CONDUCTED X-RAYS, AN MRI OF THE LUMBAR SPINE WITHOUT CONTRAST, FLUOROSCOPY, AND EPIDUROGRAM WITH STEROID INJECTION AT L2-L3. PATIENT WAS THEN DISCHARGED TO A SKILLED NURSING FACILITY. ON (B)(6)2021, PATIENT UNDERWENT RIGHT HIP HEMIARTHROPLASTY AND REMOVAL OF THE HARDWARE. UPON INSPECTION OF THE HARDWARE, THE FNS PLATE HAD BROKEN. POSTOPERATIVELY, THE PATIENT SUFFERED SIGNIFICANT SWELLING IN BILATERAL LOWER EXTREMITIES CAUSED BY DE

  Patient problems: Inflammation; Necrosis; Unspecified Infection

  MAUDE report 17134675 ↗
• MalfunctionJan 23, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN FNS CASE, THE GUIDEWIRE WAS MEASURED TO DETERMINE THE LENGTH OF THE LOCKING BOLT. WHEN THE STEPPED REAMER WAS SET TO THE CORRECT LENGTH AND BEGAN TO REAM, IT WAS REALIZED UNDER X-RAY THAT THE MEASUREMENT WAS INCORRECT AND THE STEPPED REAMER WOULD HAVE PENETRATED THE FEMORAL HEAD IF REAMING WERE TO BE CONTINUED. THE CORRECT GUIDEWIRE AND MEASURING DEVICE FROM THE FNS SET WAS USED. THE STERILE BOXED 105MM FNS BOLT WAS OPENED WHEN IT WAS DETERMINED IT WOULD BE THE INCORRECT SIZE. THE SURGEON ATTEMPTED TO PUT IN THE 105MM BOLT, BUT IT WAS GOING TO BE TO LONG SO A 100MM BOLT WAS OPENED. IT WAS UNKNOWN IF THERE WAS ANY PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) BOLT FOR FEMORAL NECK SYS 105 LENGTH-S. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16229876 ↗
• DeathNov 10, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT RIGHT HIP HEMIARTHROPLASTY AND REMOVAL OF THE HARDWARE. UPON INSPECTION OF THE HARDWARE THE DEPUY SYNTHES FEMORAL NECK SYSTEM HAD BROKEN COMPLETELY THROUGH THE PLATE. THE PATIENT STRUGGLED FROM THIS PROCEDURE AND SUFFERED SIGNIFICANT SWELLING IN HIS BILATERAL LOWER EXTREMITIES WHICH WAS CAUSED BY DEEP VEIN THROMBOSIS IN HIS POPLITEAL VEIN. THE PATIENT SUBSEQUENTLY DEVELOPED AN INFECTION WHICH REQUIRED A THIRD PROCEDURE TO REMOVE THE HARDWARE AND PUT IN AN ANTIBIOTIC SPACER ON (B)(6) 2021. ON (B)(6) 2021 THE PATIENT DIED DUE TO CARDIAC ARREST, ANEMIA POST OP, SEPTIC RIGHT HIP AND THROMBOSIS OF THE LEFT ARM AND RIGHT LEG. ON OR ABOUT (B)(6) 2020 THE PATIENT SUFFERED A FALL AT HIS HOME, WHILE CARRYING A FEW GALLONS OF WATER ON HIS PROPERTY WHICH INCLUDED A SLOPING DRIVEWAY. X-RAY REPORTED A RIGHT INTERTROCHANTERIC FRACTURE AND A CT WHICH CONCLUDED THAT HE HAD IMPACTED COMMINUTED RIGHT INTERTROCHANTERIC FRACTURE. ON (B)(6) 2020 THE PATIENT UNDERWENT OPEN TREATMENT OF THE RIGHT FEMORAL NECK FRACTURE WITH A SCREW AND SIDE PLATE. ON (B)(6), 2021 THE PATIENT COMPLAINTS OF WORSENING RIGHT HIP PAIN AND LOWER EXTREMITY EDEMA. STATED TH

  Patient problems: Pain; Post Operative Wound Infection; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 15769700 ↗
• InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 3 OF 4 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT POSTOPERATIVELY TO AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2022, THE PATIENT HAD A REVISION PROCEDURE TO A TOTAL HIP ARTHROPLASTY ON (B)(6) 2022 AS THE FEMORAL NECK SYSTEM DEVICES COLLAPSED. ACCORDING TO THE REPORT, THE IMPLANTS WERE INSIDE THE PATIENT FOR ROUGHLY ONE MONTH. THE STATUS OF THE PATIENT POST-REVISION PROCEDURE WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR (1) BOLT FOR FEMORAL NECK SYS 105 LENGTH-S DEVICE. THIS COMPLAINT INVOLVES 4 DEVICES.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14169901 ↗
• 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) BOLT FOR FEMORAL NECK SYS 105 LENGTH-S. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12909587 ↗