NA 04.168.505SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982274632), received between Dec 1, 2021 and Nov 10, 2022 — classified as 1 death, 2 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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; Post Operative Wound Infection; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 15769656 ↗
• InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 4 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) ANTIROTATION SCR FEM NECK 105 LNTH - S DEVICE. THIS COMPLAINT INVOLVES 4 DEVICES.

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

  MAUDE report 14170042 ↗
• 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) ANTIROTATION SCR FEM NECK 105 LNTH - S. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 12909589 ↗