Vivacit-E® 110031017Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
All models of Vivacit-E (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00889024572751), received between Aug 5, 2024 and Aug 5, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- Joint Dislocation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 8 DAYS POST IMPLANTATION DUE TO A FALL THAT RESULTED IN A HIP DISLOCATION. ON THE POST-DISLOCATION X-RAYS, THE POLYETHYLENE INSERT SEEMS CORRECTLY FITTED TO THE HEAD. THE POST-REDUCTION X-RAY ALSO SHOWS THAT THE INSERT IS NO LONGER COUPLED TO THE HEAD, ONLY THE HEAD IS IN THE CUP AND THE INSERT IS IN THE SOFT TISSUES ON THE POSTEROSUPERIOR PART OF THE HIP WHICH WILL BE CONFIRMED DURING THE RECOVERY. IN ADDITION, IT APPEARS THAT THE HEAD IS NOT CENTERED. THERE IS A SHAPE OF A SPHERE THAT MAKES THE SURGEON THINK THAT IT IS DISASSOCIATED FROM THE CUP BUT AS THE HEAD AND CUP IS IN PLACE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 19907607 ↗
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, 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-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-0057-2021 · Aug 14, 2020 · TerminatedDual Mobility Vivacit-E Bearing, Model Number 110031009
Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices
- STAGEONE 431209Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 recalls0 reports
- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page