Vivacit-E® 110031313Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024572812), received between Jun 17, 2025 and Aug 11, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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
- Detachment of Device or Device Component2
- Device Dislodged or Dislocated1
Patient problems
- Failure of Implant1
- Joint Dislocation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 11, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: Joint Dislocation
MAUDE report 22769431 ↗InjuryJun 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO DISASSOCIATION OF THE BEARING AND COMPETITOR. THE CUP AND BEARING WERE REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 22236113 ↗
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 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.