Vivacit-ERecalls & reported problems across all models
Zimmer, Inc. · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Vivacit-E model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 101
- Deaths reported
- 0
- Injuries reported
- 83
- Recalls
- 2
We found 11 models of Vivacit-E by Zimmer, Inc. in the FDA's device registry (GUDID). Together they are named in 101 adverse event reports in the FDA's MAUDE database, received between Aug 26, 2020 and Sep 30, 2026 — classified as 83 injuries, 18 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (49 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Vivacit-E recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · Recall details · FDA record ↗
- 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 · Recall details · FDA record ↗
Most reported Vivacit-E problems
Device problems
- Device Dislodged or Dislocated49
- Detachment of Device or Device Component32
- Adverse Event Without Identified Device or Use Problem13
- Device Markings/Labelling Problem7
- Packaging Problem6
- Fracture3
- Insufficient Device Problem Information3
- Naturally Worn2
Patient problems
- Joint Dislocation55
- No Clinical Signs, Symptoms or Conditions16
- Failure of Implant11
- Insufficient Information10
- Pain6
- Unspecified Infection5
- Ambulation or Postural Difficulties4
- No Code Available3
Vivacit-E models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Vivacit-E® 110031012Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented1 recall33 reports
- Vivacit-E® 110031013Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1 recall15 reports
- Vivacit-E® 110031009Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented25 reports
- Vivacit-E® 110031010Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented11 reports
- Vivacit-E® 110031011Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented6 reports
- Vivacit-E® 110031015Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented3 reports
- Vivacit-E® 110031314Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented3 reports
- Vivacit-E® 110031313Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented2 reports
- Vivacit-E® 110031014PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Vivacit-E® 110031016PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
- Vivacit-E® 110031017Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
Recent Vivacit-E adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryAug 26, 2026Device Dislodged or Dislocated
It was reported that the patient underwent a hip revision approximately 1-year post-implantation due to joint dislocation. Initially, the surgeon attempted to reduce the dislocation; however, an intraprosthetic dislocation occurred. Subsequently, the liner and DM bearing were revised. No additional information available for the reported event.
Patient problems: Joint Dislocation
MAUDE report 50460389 ↗InjuryJul 8, 2026Detachment of Device or Device Component; Device Dislodged or Dislocated
IT WAS REPORTED THAT APPROXIMATELY SIX WEEKS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO DISLOCATION. CUP WAS EXPLANTED AND A NEW CONSTRAINED LINER IMPLANTED. THERE WAS NO KNOWN IMPACT OR CONSEQUENCES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Dislocation
MAUDE report 25746514 ↗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 ↗InjuryApr 24, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 19 MONTHS POST-IMPLANTATION DUE TO DISASSOCIATION OF THE BEARING AND HEAD. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 24983243 ↗InjuryMar 31, 2026Detachment of Device or Device Component
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24740590 ↗InjuryMar 30, 2026Detachment of Device or Device Component
NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24727265 ↗MalfunctionFeb 18, 2026Positioning Failure; Unclear Information
IT WAS REPORTED THAT DURING AN INITIAL TOTAL HIP ARTHROPLASTY, THE CORRECT INLAY WAS OPENED FOR THE SHELL HOWEVER THE INLAY WOULD NOT FIT AND WAS UNABLE TO BE PROPERLY POSITIONED. A BACKUP DEVICE WAS USED TO THE COMPLETE THE PROCEDURE WITHOUT FURTHER COMPLICATION. THERE WAS NO PATIENT IMPACT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24380550 ↗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 ↗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 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 ↗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 ↗
Other Zimmer, Inc. products
- PERSONA364 models · 2,000 reports · 3 recalls
- Persona The Personalized Knee77 models · 1,396 reports
- PERSONA Vivacit-E285 models · 1,152 reports
- NexGen198 models · 842 reports · 4 recalls
- Affixus18 models · 1 reports · 17 recalls
- PERSONA Natural Tibia25 models · 417 reports · 2 recalls
- NexGen Legacy119 models · 319 reports · 3 recalls
- Alliance32 models · 275 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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.
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