NA 802203202Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00889024498839), received between Jul 24, 2023 and Sep 16, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2025Inadequacy of Device Shape and/or Size; Improper or Incorrect Procedure or Method; Inadequacy of Device Shape and/or Size; Improper or Incorrect Procedure or Method

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23062444 ↗
• InjuryMar 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Joint Dislocation

  MAUDE report 21688801 ↗
• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 21291305 ↗
• InjuryDec 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 19 DAYS POST IMPLANTATION DUE TO AN INFECTION AND SUBLUXATION OF THE HEAD AND LINER. PATIENT WAS NOTED TO HAVE A POSITIVE CULTURE FOR ENTEROCOCCUS FAECALIS PROTEUS MIRABILIS. PATIENT WAS GIVEN DICLOXACILLIN BY MOUTH FOR APPROXIMATELY 3 MONTHS. IT WAS NOTED DURING THE REVISION PROCEDURE, THE SURGEON NOTED NECROTIC INFECTED TISSUE. THERE IS NO ADDITIONAL INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Bacterial Infection; Subluxation; Tissue Breakdown

  MAUDE report 20824794 ↗
• InjuryMar 29, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED ONE YEAR POST IMPLANTATION DUE TO DISLOCATION DUE TO PLACEMENT OF THE ACETABULAR COMPONENT. THE HEAD, LINER, AND SHELL WERE EXCHANGED.

  Patient problems: Discomfort; Joint Dislocation; Pain

  MAUDE report 19006038 ↗
• InjuryDec 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Joint Dislocation

  MAUDE report 18363561 ↗
• InjuryDec 20, 2023Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bacterial Infection; Joint Dislocation

  MAUDE report 18363329 ↗
• InjuryDec 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP REPLACEMENT. SUBSEQUENTLY, THE PATIENT HAD A FALL, LANDING ON THE HIP THAT WAS REPLACED, CAUSING THE DISLOCATION. THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 1 MONTH POST IMPLANTATION. PERIOPERATIVELY, THE SURGEON DECIDED TO EXCHANGE THE SHELL DUE TO SHELL MALPOSITION AND THE LINER FOR AN ELEVATED LINER. ON REMOVAL OF THE FEMORAL HEAD, THE STEM WAS REMOVED AND EXCHANGED FOR THE SAME OFFSET AND SIZE. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 18317692 ↗
• InjuryDec 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 18277588 ↗
• InjuryJul 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY TWO MONTHS¿ POST IMPLANTATION DUE TO A DISLOCATION. A SMALL AVULSION OF THE POSTERIOR GREATER TROCHANTER NOTED AT START, AS WELL AS RUPTURED FASCIAL REPAIR. ATTEMPTS WERE MADE AT CLOSED REDUCTION BUT WERE UNSUCCESSFUL. IT WAS THEN DECIDED TO COMPLETE AN OPEN REDUCTION. THE HEAD WAS EXCHANGED WITHOUT ANY KNOWN COMPLICATIONS.

  Patient problems: Bone Fracture(s); Joint Dislocation; Muscle/Tendon Damage; Unequal Limb Length

  MAUDE report 17379425 ↗