NA 802202803Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00889024498792), received between Jun 27, 2022 and Jul 30, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Device Dislodged or Dislocated

  It was reported that the patient underwent a revision approximately 3 days post-implantation due to dislocation. A patient was involved requiring revision surgery.Attempts have been made and no further information has been provided.

  Patient problems: Joint Dislocation

  MAUDE report 50082117 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ONE DAY POST RIGHT HIP SURGERY; THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR AN UNKNOWN CARDIAC ISSUE. IT IS UNKNOWN WHAT TREATMENT WAS PROVIDED OR WHY THE PATIENT NEEDED TO BE TRANSFERRED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 23819368 ↗
• InjuryJul 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL, LEFT HIP ARTHROPLASTY. APPROXIMATELY 2 (TWO) MONTHS LATER, THE STEM DISASSOCIATED FROM THE HEAD AFTER THE PATIENT FELL, LEADING TO A REVISION. THE HEAD, LINER AND CUP WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 22393103 ↗
• InjuryFeb 20, 2025Unstable; Unstable

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Pain; Unequal Limb Length

  MAUDE report 21421346 ↗
• InjuryJan 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 2 AND A HALF MONTHS POST IMPLANTATION DUE TO RECURRENT DISLOCATION. THE PATIENT'S INITIAL DISLOCATION OCCURRED AFTER THE PRIMARY SURGERY WHEN NO MEDICAL INTERVENTION WAS PERFORMED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 21267382 ↗
• InjuryOct 30, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY TWO MONTHS POST IMPLANTATION DUE TO A DISLOCATION. THE HEAD AND LINER WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 20566066 ↗
• InjuryAug 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 19891909 ↗
• InjuryMay 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED ON NEARLY ONE (1) MONTH POST IMPLANTATION DUE TO WOULD LEAKING PUS. THE PATIENT HAD A FALL UNRELATED TO THE HIP ARTHROPLASTY. IT WAS NOTED THAT THE PATIENT SUFFERED FROM MENTAL HEALTH ISSUES AND WAS IN OVERALL POOR HEALTH AT THE TIME OF THE INCIDENT. THE SURGICAL TECHNIQUE OF THE PRODUCT WAS UTILIZED.

  Patient problems: Wound Dehiscence

  MAUDE report 19418469 ↗
• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 17038907 ↗
• InjuryDec 13, 2022Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT UNDERWENT A LEFT INITIAL HEMIARTHROPLASTY THAT WAS SUBSEQUENTLY REVISED APPROXIMATELY 3 (THREE) MONTHS LATER DUE TO DISLOCATIONS FROM RECURRENT FALLS. THE SHELL, LINER, AND HEAD WERE EXCHANGED WITHOUT COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND THE ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 15973537 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 1 MONTH POST IMPLANTATION DUE TO INFECTION. THE MULTIPOLAR HEAD CONSTRUCT WAS REMOVED AND REPLACED, WHILE THE CPT STEM REMAINS IMPLANTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 14828860 ↗