Vivacit-E® 110031012Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00889024572706), received between Nov 3, 2020 and Sep 30, 2026 — classified as 29 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (16 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-0418-2026 · Root cause: Labeling mix-ups · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Device Dislodged or Dislocated

  Patient problems: Joint Dislocation

  MAUDE report 50945077 ↗
• InjurySep 28, 2026Detachment of Device or Device Component

  Patient problems: Joint Dislocation

  MAUDE report 50920091 ↗
• InjuryMay 28, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A G7 DUAL MOBILITY HIP REVISION DUE TO DISLOCATION. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 25316153 ↗
• InjuryJan 29, 2026Device Dislodged or Dislocated

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Joint Dislocation

  MAUDE report 24209496 ↗
• InjuryJan 7, 2026Detachment of Device or Device Component

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

  Patient problems: Joint Dislocation

  MAUDE report 23995494 ↗
• MalfunctionDec 30, 2025Nonstandard Device; Nonstandard Device

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23920560 ↗
• InjuryNov 14, 2025Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE SURGEON WAS NOTIFIED OF AN IMPLANT RECALL DUE TO A SIZE DISCREPANCIES THREE WEEKS AFTER THE PATIENT WAS IMPLANTED WITH THE RECALLED DM BEARING. MEDICAL RECORDS INDICATE THAT THE PATIENT WAS OVERALL SATISFIED WITH THE SURGERY AND POSTOP PROGRESS WITH MILD PAIN AND A LIMB LENGTH DISCREPANCY OF +1CM ON THE RIGHT SIDE. THE DISCREPANCY WAS CORRECTED WITH SHOE MODIFICATIONS; HOWEVER, NO FURTHER TREATMENT OR INTERVENTION WAS PLANNED AT THE TIME. SUBSEQUENTLY, THE PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 4 MONTHS POST IMPLANTATION DUE TO INCORRECT SIZING OF THE DM BEARING. IT WAS CONFIRMED THAT NO FURTHER INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unequal Limb Length

  MAUDE report 23553494 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY FOLLOWED BY A REVISION FIVE MONTHS POST-OPERATIVE DUE TO THREE RECURRENT DISLOCATIONS. A SECOND REVISION WAS PERFORMED APPROXIMATELY 9 YEARS DUE TO PAIN AND OSSIFICATION. TWO MONTHS POST-SECOND REVISION, PATIENT UNDERWENT A DAIR FOR WOUND DEHISCENCE A THIRD REVISION DUE TO RECURRENT DISLOCATIONS. FOLLOWING THE REVISION, EXPERIENCED EXCRUCIATING PAIN DUE A FRACTURED ACETABULAR SCREW AND UNDERWENT A FOURTH REVISION. DURING THE PROCEDURE, THE PATIENT REPORTS, THE CONSTRUCT FELL PART IN THE SURGEONS AND THE GLUTEUS MUSCLES WERE DAMAGE. SUBSEQUENTLY, FOLLOWING THE PROCEDURE, THE RIGHT QUAD MUSCLE IS NOT FIRING, LEADING TO AN INABILITY TO WALK. THE PATIENT IS ALLEGING THAT DURING THE FOURTH REVISION, A NERVE WAS FLATTENED FROM EITHER THE FRACTURED SCREW OR THE PROCEDURE. NERVE CONDUCTION STUDIES HAVE BEEN PERFORMED AND IDENTIFIED FEMORAL NEUROPATHY. ALL IMPLANTS REMAIN IMPLANTED AT THIS TIME AND THEN PATIENT IS PLANNING TO BE ADMITTED TO AN INPATIENT REHABILITATION CENTER FOR AN INTENSE REHAB PROGRAM. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Nerve Damage; Neuropathy

  MAUDE report 23543850 ↗
• MalfunctionNov 10, 2025Packaging Problem; Packaging Problem

  NO ADDITIONAL INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23508770 ↗
• MalfunctionOct 30, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  NO ADDITIONAL EVENT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23423340 ↗
• MalfunctionOct 29, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT DURING SURGERY THE BEARING WAS OPENED AND THE COMPONENTS WOULD NOT FIT TOGETHER PROPERLY. IT WAS THOUGHT THAT COMPONENTS NEEDED ADJUSTING SO ALL COMPONENTS WERE DISCARDED AND REPLACED WITH ALTERNATIVES. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23412209 ↗
• InjuryOct 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  NO ADDITIONAL EVENT INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 23310528 ↗
• InjuryAug 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

  Patient problems: Joint Dislocation

  MAUDE report 22848540 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-IMPLANTATION, THE PATIENT IS EXPERIENCING MULTIPLE ISSUES: A METALLIC TASTE IN THE MOUTH AND HAS CORRESPONDING NICKEL ALLERGY; A RASH ON THEIR LEG; FEELINGS OF THEIR FEMUR SHIFTING; TWO ROUNDS OF ANTIBIOTIC TREATMENT AND IV ANTIBIOTICS FOR INFECTION; INABILITY TO WALK MUCH; TOES GO NUMB WHEN LAYING ON SIDE; HEART ATTACK LIKE SYMPTOMS; BACK PAIN; POTASSIUM AND MAGNESIUM INFUSIONS FOR UNKNOWN REASON MAKING THEM FEEL WORSE; ALLEGED METAL IN URINE THAT SURGEON THINKS IS A KIDNEY STONE; OTHER GREEN PARTICLES IN URINE SUSPECTED AS SUTURE PIECES. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Hypersensitivity/Allergic reaction; Metal Related Pathology; Pain; Unspecified Infection

  MAUDE report 22809634 ↗
• InjuryAug 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: Joint Dislocation

  MAUDE report 22778905 ↗
• InjuryAug 1, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT APPROXIMATELY THREE WEEKS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO A DISLOCATION. THE PATIENT WAS EXPERIENCING PAIN. THE SURGEON TRIED TO REINTRODUCE THE HIP INTO THE SOCKET AND THEN THE HEAD CAME OUT OF THE BEARING. WHEN REVISING, THE BEARING WAS LOOSE IN THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 22693378 ↗
• InjuryJun 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT UNDERWENT A HIP ARTHROPLASTY AND WAS IMPLANTED WITH ZIMMER BIOMET PRODUCTS. SUBSEQUENTLY, THE PATIENT WAS REVISED TWO (2) MONTHS POST IMPLANTATION DUE TO DISLOCATION OF THE UNDERSIZED STEM. STEM, BEARING, AND LINER WERE EXPLANTED.

  Patient problems: Joint Dislocation

  MAUDE report 22168813 ↗
• InjuryApr 2, 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 TWO YEARS LATER DUE TO DISLOCATION. THE HEAD AND LINER WERE REPLACED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 21752268 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A RIGHT HIP REVISION DUE TO INSTABILITY. THE BEARING AND HEAD WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19917617 ↗
• InjuryJul 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE ONE MONTH POST IMPLANTATION DUE TO DISLOCATION OF THE HEAD/BEARING CONSTRUCT FROM THE ACETABULAR COMPONENT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Joint Dislocation

  MAUDE report 19666932 ↗
• InjuryJun 19, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST-IMPLANTATION, THE PATIENT UNDERWENT A LEFT HIP REVISION DUE TO A DISLOCATION FOR UNKNOWN REASONS AND DISASSOCIATION OF THE DUAL MOBILITY WITH INSTABILITY UPON REDUCTION. THE DECISION WAS MADE TO REVISE THE PATIENT TO A CONSTRAINED PRODUCT. THE STEM WAS RETAINED. THE HEAD AND ACETABULAR COMPONENTS WERE REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Joint Dislocation

  MAUDE report 19566991 ↗
• InjuryApr 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 10 MONTHS LATER DUE TO DISSOCIATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19144037 ↗
• InjuryMar 29, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

  Patient problems: Joint Dislocation

  MAUDE report 19002696 ↗
• InjuryMar 27, 2024Device 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 AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information; Joint Dislocation; Joint Laxity

  MAUDE report 18987555 ↗
• InjuryNov 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: Failure of Implant

  MAUDE report 18143208 ↗

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-0057-2021 · Aug 14, 2020 · Terminated
  Dual Mobility Vivacit-E Bearing, Model Number 110031009