Vivacit-E® 110031010Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00889024572683), received between May 23, 2022 and Aug 26, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 reports).

3 other recalls cover devices cleared under the same FDA submission (K190656); they may or may not involve this specific model.

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 16, 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.

• InjuryAug 26, 2026Device Dislodged or Dislocated

  It was reported that the patient underwent a hip revision approximately 1-year post-implantation due to joint dislocation. Initially, the surgeon attempted to reduce the dislocation; however, an intraprosthetic dislocation occurred. Subsequently, the liner and DM bearing were revised. No additional information available for the reported event.

  Patient problems: Joint Dislocation

  MAUDE report 50460389 ↗
• InjuryApr 24, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 19 MONTHS POST-IMPLANTATION DUE TO DISASSOCIATION OF THE BEARING AND HEAD. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 24983243 ↗
• InjuryOct 24, 2025Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

  Patient problems: Joint Dislocation; Metal Related Pathology

  MAUDE report 23377916 ↗
• InjuryOct 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 5 WEEKS LATER DUE TO DISLOCATION. DURING THE REVISION, THE DISTAL SCREW WAS ENGAGED HOWEVER THE PROXIMAL BODY WAS LOOSE AND ABLE TO ROTATE. THE PROXIMAL BODY, HEAD AND LINER WERE REVISED TO A LONGER CONSTRUCT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Aseptic loosening; Joint Dislocation

  MAUDE report 23277288 ↗
• InjuryAug 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SAME DAY AS INITIAL IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 22686465 ↗
• InjuryJun 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT APPROXIMATELY ONE DAY POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO A FALL THAT WAS CAUSED BY PAIN AND THEN THE HIP DISLOCATED. DURING SURGERY, THE SURGEON FOUND AN INTRA-PROSTHETIC DISLOCATION OF THE HEAD OUT OF THE BEARING. THE HEAD AND BEARING WERE REVISED.

  Patient problems: Failure of Implant; Joint Dislocation; Pain

  MAUDE report 19615466 ↗
• InjuryApr 11, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 2 YEARS AND 5 MONTHS POST IMPLANTATION DUE TO DISLOCATION. AT THE TIME OF THE SURGERY, THE DUAL MOBILITY LINER WAS OFF HEAD AND BEARING. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Joint Dislocation

  MAUDE report 19086636 ↗
• InjuryNov 6, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED NEARLY TWO MONTHS POST IMPLANTATION DUE TO THE DUAL MOBILITY BEARING DISLOCATING FROM THE FEMORAL HEAD. THE PATIENT WAS ABOUT SIX WEEKS POST OPERATIVE AND BENT OVER TO PICK SOMETHING UP AND DISLOCATED HER HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18072272 ↗
• InjuryAug 29, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A PATIENT UNDERWENT A HIP PROCEDURE APPROXIMATELY TWO YEARS POST IMPLANTATION DUE TO A DISLOCATION. THIS WAS CORRECTED WITH NONITERATIVE REPOSITIONING. NO IMPLANTS WERE REMOVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 17641007 ↗
• InjuryMar 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 16592038 ↗
• InjuryMay 23, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Hyporesponsive to stimuli; Joint Dislocation

  MAUDE report 14468421 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K190656. One submission often covers many models, so check the product and lot details in each record.

• Z-0419-2026 · Sep 26, 2025 · Open, Classified
  Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing, Model/Catalog Number: 110031013; semi constrained hip prosthesis
• Z-0418-2026 · Sep 26, 2025 · Open, Classified
  Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number: 110031012; semi constrained hip prosthesis
• Z-0057-2021 · Aug 14, 2020 · Terminated
  Dual Mobility Vivacit-E Bearing, Model Number 110031009