Zimmer® Nexel® Total Elbow Vivacit-E® Highly Crosslinked Polyethylene 00-8400-095-00Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024271463), received between Apr 17, 2019 and Apr 24, 2025 — classified as 6 injuries.
The most frequently reported specific device problem is “Naturally Worn” (2 reports).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Naturally Worn2
- Adverse Event Without Identified Device or Use Problem1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Material Erosion1
- No Apparent Adverse Event1
- Noise, Audible1
- Unintended Movement1
Patient problems
- Pain3
- Failure of Implant2
- Osteolysis2
- High metal ion levels1
- Joint Laxity1
- Loss of Range of Motion1
- Patient Problem/Medical Problem1
- Radiolucent Lines1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryApr 24, 2025Unintended Movement; Noise, Audible; Loosening of Implant Not Related to Bone-Ingrowth; Unintended Movement; Noise, Audible; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ELBOW REVISION APPROXIMATELY SEVEN (7) MONTHS POST-IMPLANTATION DUE TO SQUEAKING OF ELBOW AND EXCESSIVE ROM. THE SURGEON ORIGINALLY PLANNED TO REVISE DISTAL BODY; HOWEVER, THE WHOLE IMPLANT WAS LOOSE AND WAS REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Joint Laxity
MAUDE report 21898696 ↗InjuryNov 15, 2024Material Erosion; Material Erosion
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION IN THE PATIENT'S TISSUE; DURING REVISION THE DOCTOR OBSERVED METAL SHAVINGS IN THE INNER POLY OF THE ELBOW. THERE WAS HARM OR INJURY TO PATIENT AS THE PATIENT HAD TO UNDERGO ADDITIONAL SURGICAL/MEDICAL PROCEDURE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: High metal ion levels; Unspecified Infection
MAUDE report 20695569 ↗InjuryJan 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Loss of Range of Motion; Osteolysis; Pain
MAUDE report 18578744 ↗InjuryNov 14, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO COMPONENT LOOSENING AND POLY WEAR APPROXIMATELY TWO YEARS AND SEVEN MONTHS POST IMPLANTATION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: Failure of Implant; Osteolysis; Pain; Radiolucent Lines
MAUDE report 18136852 ↗InjuryMay 16, 2023Naturally Worn; Naturally Worn
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Pain; Synovitis
MAUDE report 16942084 ↗InjuryApr 17, 2019No Apparent Adverse Event; No Apparent Adverse Event
NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME
Patient problems: Patient Problem/Medical Problem; Reaction
MAUDE report 8524096 ↗
Other PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED devices
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- Arcos Modular Revision Hip System 11-301321Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall7 reports
- DJO SURGICAL 540-01-001Encore Medical, L.P. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED55 reports
- Arcos Modular Revision Hip System 11-301302Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall5 reports
- Arcos Modular Revision Hip System 11-301343Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall1 report
- ARROW IPN037140Teleflex Incorporated · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall0 reports
- Comprehensive® SRS / Discovery® 211251Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall0 reports
- Arcos Modular Revision Hip System 11-301325Biomet Orthopedics, LLC · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 recall0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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