NA 04.268.000SRecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10886982274458), received between Jul 16, 2019 and Dec 11, 2025 — classified as 1 death, 30 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, INSERTION HANDLE INSERT NOT COUPLING PROPERLY. THERE WAS NO PATIENT CONSEQUENCES. THERE WAS NO DELAYED DUE TO THE REPORTED EVENT. PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23781812 ↗
• MalfunctionSep 11, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE, THE LOCKING TOWERS WERE STRIPPED AND THE DEPTH GAUGES WERE BENT. THE FNS BOLT AND SCREWS DIDN¿T LOCK, DIDN¿T BILL. THE SOFT TISSUE REDUCTION DID NOT SNAP IN. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23027442 ↗
• MalfunctionSep 11, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE, THE LOCKING TOWERS WERE STRIPPED AND THE DEPTH GAUGES WERE BENT. THE FNS BOLT AND SCREWS DIDN¿T LOCK, DIDN¿T BILL. THE SOFT TISSUE REDUCTION DID NOT SNAP IN. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23026855 ↗
• InjurySep 5, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, SURGEON INFORMED THAT A PATIENT CAME INTO CLINIC WITH A POTENTIALLY BROKEN FEMORAL NECK SYSTEM (FNS) IMPLANT. THE FNS TWO HOLE PLATE BROKE AT THE PROXIMAL LOCKING SCREW HOLE. FNS IMPLANT WAS REMOVED ON (B)(6) 2024 AND REPLACED WITH A HEMI ARTHROPLASTY. THIS REPORT IS FOR ONE (1) FEMORAL NECK SYSTEM PLATE 2 HOLE - STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20147187 ↗
• InjuryJul 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A PATIENT UNDERWENT A REMOVAL OF FEMORAL NECK SYSTEM (FNS) DUE TO SECONDARY FRACTURE POST-OPERATIVE. PATIENT'S FEMUR WAS REVISED TO TROCHANTERIC FIXATION NAIL ADVANCED (TFNA). NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) FEMORAL NECK SYSTEM PLATE 2 HOLE - STERILE THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 19812103 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FEMUR FRACTURED AT DISTAL TIP OF FEMORAL NECK SYSTEM PLATE. FNS REMOVED AND CONVERTED TO TOTAL HIP. THIS REPORT IS FOR ONE (1) FEMORAL NECK SYSTEM PL 2 HOLE - STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Limb Fracture

  MAUDE report 17484053 ↗
• InjuryAug 8, 2023Device-Device Incompatibility; Migration; Device-Device Incompatibility; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FNS (FEMORAL NECK SCREW) CUTOUT. DURING A REMOVAL PROCEDURE, THE FNS LOCKING SCREW WAS COLD WELDED INTO THE PLATE. THE PATIENT HAD AN ADDITIONAL FRACTURE DURING REMOVAL OF THE SCREW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, BUT TOOK LONGER THAN EXPECTED ACCORDING TO THE SURGEON. THE PATIENT OUTCOME WAS SATISFACTORY. THIS REPORT INVOLVES ONE FEMORAL NECK SYSTEM PLATE 2 HOLE - STERILE. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 17479967 ↗
• InjuryAug 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2023, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A FEMORAL NECK FRACTURE WITH THE FEMORAL NECK SYSTEM. ON (B)(6) 2023 THE PATIENT SUSTAINED A STANDING HEIGHT FALL; X RAY IMAGES TAKEN REVELED A FRACTURE DISTAL TO THE FEMORAL NECK SYSTEM (FNS) PLATE. THE PATIENT WAS BROUGHT TO THE OR ON (B)(6) 2023 FOR REMOVAL OF THE FNS AND REVISION TO LONG TFNA NAIL. THIS REPORT IS FOR ONE (1) FEMORAL NECK SYSTEM PLATE 2 HOLE - STERILE. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 17475300 ↗
• InjuryJul 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6), 2023, THE SURGEON TOOK OUT THE PLATE, BOLT, ANTI ROTATIONAL AND LOCKING SCREWS AND REVISED IT WITH A LONG FEMUR IM NAIL, (SMITH AND NEPHEW INERTAN ). THE ACTUAL FNS PLATE, BOLT AND SCREWS OR THE COMPLETE IMPLANT CONSTRUCT WAS NOT DAMAGED AT TIME OF EXTRACTION; WHEN THE EXTRACTION TOOK PLACE, IT WAS SEEMED THE PATIENT FELL AND FRACTURED HER FEMUR BELOW THE PLATE OR BELOW THE MOST DISTAL SCREWS IN THE PLATE. THIS REPORT IS FOR ONE (1) NECK FIX PLATE 2HO TAN. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Fall; Limb Fracture

  MAUDE report 17248843 ↗
• 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, TO (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 EXTR

  Patient problems: Inflammation; Necrosis; Unspecified Infection

  MAUDE report 17134745 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, OPEN REDUCTION/INTERNAL FIXATION SURGERY WAS PERFORMED WITH THE FNS CONSTRUCT. A REVISION SURGERY WAS PERFORMED FOR REMOVAL OF IMPLANTS DUE TO A FEMUR FRACTURE BELOW THE FNS CONSTRUCT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE FEMORAL NECK SYSTEM PLATE 2 HOLE - STERILE. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 16554594 ↗
• MalfunctionFeb 27, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE FEMORAL NECK FRACTURE OSTEOSYNTHESIS FOR FEMORAL NECK FRACTURE WITH THE PRODUCTS IN QUESTION. DURING THE SURGERY, THE SURGEON FOLLOWED THE GUIDEWIRE INSERTION, MEASUREMENT, AND DRILLING PROCEDURES, SLIDING AND ATTACHING THE PLATE TO THE INSERTION HANDLE WITH THE 2HOLE PLATE AND 95 MM NECK BOLT SET. HE INSERTED THE INSERTER FROM BEHIND AND WHEN HE DID THE SCREW INSTALLATION, A NURSE SAID IT WAS TOO HARD AND THE SCREW WOULD NOT TURN. THEY TRIED SEVERAL TIMES TO REINSERT THEM, BUT THEY NEVER SEEMED TO GO IN, SO THEY DISMANTLED EVERYTHING AND CHECKED THE IMPLANTS VISUALLY. NECK BOLT AND PLATE CONFORMITY WAS NOT A PROBLEM. THERE WAS SIGNIFICANT RESISTANCE WHEN INSERTING THE PLATE AND INSERTER. THEY PUSHED HARDER AND MANAGED TO GET THEM IN, SO THEY AGAIN ATTEMPTED TO ATTACH THE IMPLANTS USING A COMBINATION OF HANDLE AND INSERTER. IT WAS OBVIOUS TO THE NAKED EYE THAT THE INSERTER WAS MORE ADVANCED THAN AT FIRST, SO THEY USED THE T-CHUCK HANDLE OF THE JACOBS CHUCK TO FORCEFULLY TURN THE C SCREW. ALTHOUGH FORCEFUL, THE INSTALLATION WAS COMPLETED, AND SINCE THERE WERE NO APPAR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16444200 ↗
• 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 THE

  Patient problems: Pain; Swelling/ Edema; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 15769718 ↗
• InjuryMay 4, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT POSTOPERATIVELY TO AN UNKNOWN SURGERY PERFORMED ON (B)(6) 2021, AT THE TIME THE PATIENT WAS TREATED FOR FEMORAL NECK FRACTURE WITH AN FNS IMPLANT ON (B)(6) 2022, IT WAS DISCOVERED UPON FOLLOW-UP A YEAR LATER THAT PATIENT HAD A NON-UNION AND THE SURGEON DECIDED THE PATIENT CAN BE CONVERTED TO TOTAL HIP ARTHROPLASTY PROCEDURE. IT WAS DISCOVERED DURING SURGERY THAT THE FNS PLATE HAD BROKEN. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 14273085 ↗
• InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 2 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 ONE (1) FEMORAL NECK SYSTEM PL 2 HOLE - STERILE DEVICE. THIS COMPLAINT INVOLVES 4 DEVICES.

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

  MAUDE report 14169910 ↗
• 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 (5) DEVICES. THIS REPORT IS FOR (1) BOLT FOR FEMORAL NECK SYSTEM 95MM LENGTH-STERILE. THIS REPORT IS 4 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 12368395 ↗
• 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, THE PATIENT HAD AN EX-PLANTATION OF A FAILED FEMORAL NECK SYSTEM, ORIGINAL DATE OF THE SURGERY WAS (B)(6) 2020. THE PATIENT HAS A HISTORY OF SUBSTANCE ABUSE. NO FRAGMENTATION WAS OBSERVED BESIDES THE SPLIT IN THE BOLT FOR FEMORAL NECK SYSTEM AND ANTI-ROTATION SCREW. CONCOMITANT DEVICE REPORTED: FEMORAL NECK SYSTEM (PART: 04.268.000S; LOT:22P9146; QUANTITY: 1). 5.0MM LOCKING SCREWS, WITH T25 STARDRIVE (PART:412.211S;LOT:4L80139 QUANTITY: 1). 5.0MM LOCKING SCREWS, WITH T25 STARDRIVE (PART:412.210S LOT# UNKNOWN; QUANTITY:1). THIS REPORT IS FOR ONE (1) FEMORAL NECK SYSTEM PLATE 2 HOLE - STERILE. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

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

  MAUDE report 12367655 ↗
• InjuryAug 13, 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 REVISION SURGERY FOR REMOVAL OF FEMORAL NECK SYSTEM (FNS) IMPLANTS DUE TO PAIN. THE DATE OF THE ORIGINAL SURGERY WAS (B)(6) 2020. THERE WAS NO BROKEN HARDWARE. ALL IMPLANTS WERE SUCCESSFULLY REMOVED WITHOUT COMPLICATION. THIS REPORT IS FOR ONE (1) FEMORAL NECK SYSTEM PLATE 2 HOLE - STERILE. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 12320971 ↗
• 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) FEMORAL NECK SYSTEM PL 2 HOLE, STERILE. THIS REPORT IS 1 OF 5 FOR (B)(4).

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

  MAUDE report 12081209 ↗
• InjuryJun 10, 2021Break; Break

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT A PROCEDURE DURING WHICH A SURGEON NOTED THAT THE FEMORAL NECK SYSTEM 2-HOLE PLATE WAS BROKEN. CONCOMITANT DEVICES REPORTED: UNKNOWN FNS ANTI-ROTATION SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNKNOWN FNS BOLT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNKNOWN LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS REPORT IS FOR ONE (1) FEMORAL NECK SYSTEM PLATE 2 HOLE - STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

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

  MAUDE report 11975529 ↗
• InjuryFeb 5, 2021Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT THE FEMORAL NECK SYSTEM (FNS) REMOVAL ON (B)(6) 2021 DUE TO FNS NAIL BREAKAGE. THE IMPLANT BROKE AT THE LOCKING SCREW HOLE. THE PHYSICIAN STATED THE CANAL NECK FRACTURE WAS A NONUNION AND THE IMPLANT BROKE DUE TO NON-UNION. NO FURTHER INFORMATION PROVIDED. CONCOMITANT DEVICE REPORTED: LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) FEMORAL NECK SYSTEM PLATE 2 HOLE - STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 11287185 ↗
• InjuryFeb 4, 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 REMOVAL OF FEMORAL NECK SYSTEM (FNS) DUE TO PAIN AND REPLACED WITH TOTAL HIP REPLACEMENT. HARDWARE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS REPORTED AS GOOD. NO FURTHER INFORMATION PROVIDED. CONCOMITANT DEVICES REPORTED: LOCKING SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), FNS ANTIROTATION SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), FNS BOLT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) FEMORAL NECK SYSTEM PLATE 2 HOLE - STERILE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Pain

  MAUDE report 11282763 ↗
• InjuryJan 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, A HARDWARE REMOVAL AND OPEN REDUCTION INTERNAL FIXATION (ORIF) WITH AN INTRAMEDULLARY NAIL WAS PERFORMED DUE TO SUB-TROCHANTERIC FEMUR FRACTURE. THE PATIENT ORIGINALLY UNDERWENT SURGERY FOR DISPLACED FEMORAL NECK FRACTURE ON (B)(6) 2020. AT THAT TIME, THE PATIENT WAS TREATED WITH A FEMORAL NECK SYSTEM. PATIENT SUBSEQUENTLY SLIPPED AND FELL AT HOME ON (B)(6) 2020 AND SUSTAINED A COMMINUTED SUB-TROCHANTERIC FEMUR FRACTURE. THE FNS HARDWARE WAS REMOVED AND THE PATIENT WAS IMPLANTED WITH FEMORAL RECON NAIL. THIS REPORT IS FOR ONE (1) FEMORAL NECK SYSTEM PLATE 2 HOLE - STERILE. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 11195021 ↗
• InjuryDec 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, A PATIENT UNDERWENT THE FEMORAL NECK SYSTEM (FNS) EXPLANATION PROCEDURE AS FEMORAL NECK COLLAPSED REQUIRING CONVERSION TO BI-POLAR HIP. THE PATIENT WAS REPORTED TO FALLEN ON A FEW TIMES. THE IMPLANT WAS TAKEN OUT SUCCESSFULLY, WITH NO ISSUES OR DELAY, AND SUBSEQUENT REVISION SURGERY WAS COMPLETED SUCCESSFULLY. THERE WERE TWO LOCKING SCREWS REMOVED AS WELL. PATIENT STATUS IS REPORTED AS SUCCESSFULLY CONVERTED TO BIPOLAR HIP. THIS REPORT IS FOR ONE (1) FEMORAL NECK SYSTEM PLATE 2 HOLE - STERILE. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 11100722 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ADDITIONAL FRACTURES OCCURRED POST-OPERATIVELY AND WERE CONFIRMED BY X-RAY FOR A FEMORAL NECK SYSTEM (FNS). REVISION SURGERY OCCURRED ON (B)(6) 2020, IN WHICH THE FNS IMPLANTS WERE REMOVED AND THE PATIENT REVISED TO A BIPOLAR HIP ARTHROPLASTY (BHA). THE ORIGINAL OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR FEMORAL NECK FRACTURES USING THE FNS SYSTEM OCCURRED (B)(6) 2020. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 10250290 ↗