Vivacit-E® 110031013Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00889024572713), received between Aug 27, 2020 and Dec 16, 2025 — classified as 11 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Sep 26, 2025Open, Classified

   Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.

   Z-0419-2026 · Root cause: Labeling mix-ups · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• 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 23819367 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED; A CORRECTED REPORT HAS BEEN SUBMITTED UNDER 0001822565-2026-00204.

  Patient problems: Nerve Damage

  MAUDE report 23568318 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Periprosthetic fracture

  MAUDE report 23490872 ↗
• MalfunctionNov 3, 2025Wrong Label; Wrong Label

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451014 ↗
• InjuryAug 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT APPROXIMATELY THREE WEEKS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 22836067 ↗
• MalfunctionDec 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20901623 ↗
• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 20367956 ↗
• InjuryMay 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PATIENT UNDERWENT NOTED EXPERIENCING PAIN AND ELEVATED METAL ION LEVELS. IT WAS FOUND THAT THE CERAMIC DUAL MOBILITY HEAD HAD DISASSOCIATED FROM THE HEAD CAUSING THE STEM TO ARTICULATE ON THE DUAL MOBILITY LINER. THE PATIENT ULTIMATELY UNDERWENT A REVISION SURGERY APPROXIMATELY 16 MONTHS POST IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant; High metal ion levels; Pain

  MAUDE report 16911910 ↗
• MalfunctionFeb 20, 2023Packaging Problem; Packaging Problem

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16404755 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

  Patient problems: Insufficient Information; Pain; Unspecified Infection

  MAUDE report 16156787 ↗
• MalfunctionOct 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, DURING INITIAL REDUCTION, THE DM BEARING DISASSOCIATED FROM 28 CERAMIC HEAD. THEY DID NOT HAVE ANOTHER DM BEARING, SO THEY OPENED A NEW 28MM HEAD AND PRESSED THE PARTS BACK TOGETHER, IMPLANTED AND REDUCED THE HIP. NO ADDITIONAL INFORMATION ON THE REPORTED EVENT IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15672470 ↗
• InjuryJun 6, 2022Device Dislodged or Dislocated; Therapeutic or Diagnostic Output Failure

  THE PATIENT HAD A BILATERAL TOTAL HIP ARTHROPLASTY (THA) DONE A FEW YEARS BACK AND HAD DONE WELL. PATIENT, SUBSEQUENTLY, HAD AN EXTENSIVE LUMBOSACRAL FUSION, AFTER WHICH POINT THE PATIENT DISLOCATING TOTAL HIP REPLACEMENT ANTERIORLY. CT SCANS AND ENGINEERS WITH THE CORIN GROUP OPTIMIZED POSITIONING SYSTEM (OPS) ANALYZED PATIENT'S HIPS IN THE SITTING AND STANDING POSITION AND GAVE RECOMMENDATIONS FOR THE IDEAL LOCATION OF THE ACETABULAR COMPONENT. SURGICAL/CLINICAL STAFF THEN WENT AHEAD AND DID THAT ACETABULAR REVISION APPROXIMATELY EIGHT WEEKS AGO. PATIENT HAD DONE WELL AND AT HER SIX-WEEK POSTOPERATIVE VISIT, PATIENT EXPRESSED ABSOLUTELY NO PAIN AND EVERYTHING WAS DOING VERY, VERY WELL. ABOUT ONE WEEK AGO, SOMETHING HAPPENED AND PATIENT DISLOCATED HER HIP. THERE WAS SOME CONCERN THAT THERE MAY HAVE BEEN MORE GOING ON THAN WHAT THE PATIENT SAID INITIALLY. HOWEVER, SHE SAID THAT SHE FLEXED HER HIP PAST 90 DEGREES IN THE SHOWER, ROTATED INTERNALLY AND THEN ADDUCTED HER FEMUR. THIS CAUSED THE FIRST DISLOCATION. OVER ONE WEEK SHE HAD TWO SUBSEQUENT DISLOCATIONS. BECAUSE OF THIS, WE DECIDED TO DO A REVISION. DESCRIPTION OF CATASTROPHIC FAILURE OF THE DUAL MOBILITY CONSTRUCT: AFTER THE F

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

  MAUDE report 14605118 ↗
• InjuryFeb 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT BECAME DISLOCATED AND COULD NOT BE REDUCED THROUGH CLOSED REDUCTION. HAD TO OPEN AND FOUND FEMORAL HEAD BECAME DISASSOCIATED FROM DM POLY LINER. DM CONSTRUCT REMOVED AND FREEDOM CONSTRUCT PUT IN PLACE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 13481301 ↗
• InjuryAug 24, 2021Detachment 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 SURGERY 23 DAYS POST IMPLANTATION DUE TO BEARING DISASSOCIATING FROM THE HEAD WHICH ALSO CAUSED PATIENT TO DISLOCATE. BEARING WAS REVISED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 12362330 ↗
• InjuryAug 27, 2020Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION AFTER AN UNKNOWN AMOUNT OF TIME POST IMPLANTATION. APPROXIMATELY 1 WEEK LATER, THE PATIENT PRESENTED TO THE ER WITH A DISLOCATED HIP. DURING RELOCATION IT WAS NOTICED THAT THE OUTER BEARING HAD DISSOCIATED FROM THE INNER HEAD AND THE PATIENT UNDERWENT A REVISION PROCEDURE THE NEXT DAY. THE HEAD, LINER, BEARING AND SLEEVE WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 10460647 ↗

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-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