Vivacit-E® 110031009Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
Quick summary
This Zimmer Vivacit-E hip implant replaces a damaged hip joint. Reports mostly describe the hip dislocating months after surgery, often needing another operation to replace parts or fix loose screws. There are 25 reports naming its identifier, with no deaths and 18 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00889024572676), received between Aug 26, 2020 and Dec 26, 2025 — classified as 18 injuries, 7 malfunctions.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated10
- Device Markings/Labelling Problem6
- Detachment of Device or Device Component3
- Packaging Problem3
- Adverse Event Without Identified Device or Use Problem2
- Fracture2
- Naturally Worn2
- Inaccurate Information1
Patient problems
- Joint Dislocation12
- No Clinical Signs, Symptoms or Conditions4
- No Code Available3
- No Known Impact Or Consequence To Patient3
- Failure of Implant2
- No Information2
- Aseptic loosening1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
InjuryDec 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Subluxation
MAUDE report 23896293 ↗InjuryDec 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT APPROXIMATELY 6 MONTH POST-HIP PROCEDURE, THE PATIENT UNDERWENT A HIP REVISION DUE TO DISLOCATION TO REPLACE THE HEAD AND BEARING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 23802524 ↗InjuryDec 9, 2025Naturally Worn; Naturally Worn
InjuryNov 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 23582159 ↗InjuryNov 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THERE IS NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 23476685 ↗InjuryJul 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT APPROXIMATELY FIVE MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO A DISLOCATION OF BEARING AND CUP AND INFERIOR SCREWS LOOSE IN THE BONE. THREE SCREWS WERE REMOVED AND REPLACED. A LARGER HEAD WITH MORE OFFSET WAS PLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Aseptic loosening; Joint Dislocation
MAUDE report 22529420 ↗InjuryJul 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 22412549 ↗InjuryMay 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST-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 21975861 ↗InjuryDec 4, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component
IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP REVISION APPROXIMATELY TWO YEARS AND FOUR MONTHS POST IMPLANTATION DUE TO RECURRENT DISLOCATION. DURING THE REVISION IT WAS NOTED THAT THE BEARING WAS FRACTURED AND THE HEAD DISLOCATED FROM THE BEARING. THE HEAD AND BEARING WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant; Joint Dislocation
MAUDE report 20846089 ↗MalfunctionSep 25, 2024Packaging Problem; Packaging Problem
IT WAS REPORTED THERE WAS DEBRIS IN THE STERILE PACKAGING. NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20300018 ↗MalfunctionJul 23, 2024Packaging Problem; Packaging Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19811712 ↗InjuryMar 22, 2024Adverse 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
MAUDE report 18958269 ↗InjuryJan 30, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED EIGHTEEN (18) YEARS POST IMPLANTATION DUE TO METAL RELATED PATHOLOGY. DURING THE REVISION, THE INITIAL STEM AND SHELL WERE LEFT INTACT, AND ALL OTHER COMPONENTS WERE REVISED. IT WAS FURTHER REPORTED THAT THE PATIENT REQUIRED A SECOND REVISION DUE TO DISLOCATION. THE HEAD AND LINER WERE EXCHANGED. NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 18607269 ↗InjuryJan 24, 2024Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED FROM LEGAL ALLEGATIONS THAT A PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED EIGHTEEN (18) YEARS POST IMPLANTATION DUE TO METAL RELATED PATHOLOGY. DURING THE REVISION, THE INITIAL STEM AND SHELL WERE LEFT INTACT, AND ALL OTHER COMPONENTS WERE REVISED. IT WAS FURTHER REPORTED THAT THE PATIENT REQUIRED A SECOND REVISION ONE MONTH POST IMPLANTATION DUE TO DISLOCATION WHERE THE HEAD AND LINER WERE EXCHANGED. A THIRD REVISION OCCURRED DUE TO DISLOCATION AND INFECTION. ALL COMPONENTS WERE REPLACED WITH AN UNKNOWN ANTIBIOTIC SPACER.
Patient problems: Joint Dislocation; Unspecified Infection
MAUDE report 18575064 ↗InjuryAug 22, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.
Patient problems: Joint Dislocation
MAUDE report 17595166 ↗InjuryAug 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THE PATIENT UNDERWENT A REVISION SURGERY DUE TO DISLOCATION. DURING SURGERY, THERE WAS A DECOUPLING BETWEEN THE DOME AND HEAD OF THE PROSTHETIC IMPLANTS AND THE COMPONENTS WERE REPLACED (DOME AND HEAD).
Patient problems: Joint Dislocation
MAUDE report 17574237 ↗MalfunctionApr 4, 2022Packaging Problem; Packaging Problem
IT WAS REPORTED THAT WHEN THE IMPLANT WAS OPENED THERE WAS A HAIR UNDER THE STERILE PACKAGING. NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13996665 ↗InjuryJul 20, 2021Fracture; Naturally Worn; Fracture; Naturally Worn
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12197753 ↗InjurySep 8, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THE PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 2 MONTHS POST-IMPLANTATION DUE TO THE WRONG SIZE IMPLANT BEING IMPLANTED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 10501764 ↗MalfunctionSep 8, 2020Unstable; Device Markings/Labelling Problem; Unstable; Device Markings/Labelling Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10501688 ↗MalfunctionSep 3, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem
NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10489698 ↗InjuryAug 27, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY. AN X RAY WAS TAKEN IN POST-OP, AND AN ABNORMALITY WAS SEEN. THE DOCTOR DECIDED TO RE-OPEN THE PATIENT AND EXPLANT THE CURRENT DUAL MOBILITY BEARING WITHIN. AFTER EXPLANATION, IT WAS CONFIRMED WITH CALIPERS THAT THE IMPLANTED PRODUCT WAS 42MM HOWEVER THE DESCRIPTION ON THE BOX STATED IT WAS A 38MM IMPLANT. A NEW IMPLANT WAS OPENED AND CONFIRMED AT 38MM AND WAS IMPLANTED INTO THE PATIENT. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Code Available
MAUDE report 10459118 ↗InjuryAug 26, 2020Device Markings/Labelling Problem; Device Dislodged or Dislocated; Device Markings/Labelling Problem; Device Dislodged or Dislocated
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation; No Code Available
MAUDE report 10456038 ↗MalfunctionAug 26, 2020Inaccurate Information; Inaccurate Information
IT WAS REPORTED THAT DURING TOTAL HIP ARTHROPLASTY WHEN OPENING THE LINER FOR THE SIZE 38MM HEAD, THE LINER SEEMED TO BE OF A SIZE 42 HEAD.THE DEVICE WAS IMPLANTED IN PATIENT AND SURGEON REALIZED IT WAS THE WRONG SIZE. THE DEVICE WAS REMOVED AND PART #XL-200144 LOT # 914340 WAS IMPLANTED. SURGERY WAS DELAYED BY 30 MINUTES. NO FURTHER EVENT INFORMATION AVAILABLE.
Patient problems: No Information
MAUDE report 10453706 ↗MalfunctionAug 26, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED DURING AN INITIAL HIP ARTHROPLASTY THE DUAL MOBILITY BEARING WAS OPENED AND COMBINED WITH A 28MM HEAD. SURGEON ATTEMPTED TO REDUCE BUT THE BEARING WAS TOO LARGE. IMPLANT WAS LOOKED AT CLOSELY AND APPEARED LARGER THAN THE PACKAGED 38MM. WHEN COMPARING THE TRIAL TO THE IMPLANT THE IMPLANT WAS MUCH LARGER. A NEW 38MM BEARING WAS OPENED, APPEARED TO BE THE CORRECT SIZE AND IMPLANTED. THERE WAS A 3 ¿ 5 MIN DELAY IN SURGERY. NO ADDITIONAL INFORMATION.
Patient problems: No Information
MAUDE report 10453171 ↗
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, ClassifiedZimmer 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, ClassifiedZimmer 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 · TerminatedDual Mobility Vivacit-E Bearing, Model Number 110031009
Other Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented devices
- DJO SURGICAL 942-01-40HEncore Medical, L.P. · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented2 recalls23 reports
- Vivacit-E® 110031012Zimmer, Inc. · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented1 recall33 reports
- G7® Dual Mobility Acetabular System 110024462Biomet Orthopedics, LLC · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented1 recall22 reports
- DJO SURGICAL 942-01-36HEncore Medical, L.P. · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented1 recall5 reports
- DJO SURGICAL 942-01-36JEncore Medical, L.P. · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented1 recall1 report
- DJO SURGICAL 942-01-32CEncore Medical, L.P. · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented1 recall0 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145150Biomet Orthopedics, LLC · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented46 reports
- TAPERLOC COMPLETE MICRO PRIMARY FEMORAL 51-106160Biomet Orthopedics, LLC · Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented35 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.