Zimmer® Nexel® Total Elbow Vivacit-E® Highly Crosslinked Polyethylene 00-8400-094-00Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00889024271456), received between Jan 2, 2020 and Apr 21, 2025 — classified as 11 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 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
- Adverse Event Without Identified Device or Use Problem5
- Loosening of Implant Not Related to Bone-Ingrowth5
- Difficult to Insert2
- Insufficient Device Problem Information2
Patient problems
- Failure of Implant4
- Unspecified Infection3
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
- Pain2
- Hematoma1
- High metal ion levels1
- Loss of Range of Motion1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
InjuryApr 21, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
Patient problems: Failure of Implant
MAUDE report 21872502 ↗InjuryApr 17, 2025Adverse 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: Hematoma
MAUDE report 21860134 ↗InjuryFeb 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS EVENT IS A DUPLICATE TO 0001822565-2025-00375. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
Patient problems: Osteolysis
MAUDE report 21402809 ↗InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PATIENT HAD A RIGHT TOTAL ELBOW ARTHROPLASTY APPROXIMATELY FIVE (5) YEARS AGO. SUBSEQUENTLY, DEVELOPED SIGNIFICANT PAIN AND UNDERWENT A REVISION APPROXIMATELY FORTY-ONE (41) MONTHS LATER DUE TO LOOSENING. THE CEMENTED HUMERAL COMPONENT REMAINED IMPLANTED WHILE THE CEMENTED ULNA, HUMERAL SCREWS, AND ARTICULATION KIT WERE ALL REVISED WITHOUT COMPLICATION. NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 20639866 ↗InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT IS CONSIDERING AN ELBOW REVISION PROCEDURE DUE TO UNKNOWN REASONS TO REMOVE THE HUMERAL STEM IMPLANTED APPROXIMATELY FOUR (4) YEARS AGO AND OTHER ELBOW COMPONENTS IMPLANTED APPROXIMATELY ONE AND A HALF (1.5) YEARS AGO. THIS PLANNED REVISION WILL INVOLVE REPLACEMENTS WITH COMPETITOR PRODUCTS ON AN UNKNOWN DATE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20587676 ↗InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: High metal ion levels; Unspecified Infection
MAUDE report 18170830 ↗InjuryAug 22, 2023Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth
UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
Patient problems: Failure of Implant; Loss of Range of Motion
MAUDE report 17596396 ↗MalfunctionFeb 24, 2023Difficult to Insert; Difficult to Insert
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16434952 ↗MalfunctionDec 9, 2022Difficult to Insert; Difficult to Insert
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15949260 ↗InjuryJun 29, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL ELBOW SURGERY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY SEVEN YEARS POST INITIAL PROCEDURE DUE TO EARLY ASEPTIC LOOSENING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: Failure of Implant
MAUDE report 14852698 ↗InjuryApr 13, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SECOND ELBOW REVISION PROCEDURE DUE TO IMPLANT LOOSENING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant
MAUDE report 11655330 ↗InjuryJan 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THE PATIENT IS BEING CONSIDERED FOR A REVISION TO ADDRESS INFECTION AND RELATED PAIN LESS THAN A YEAR POST IMPLANTATION. NO FURTHER INFORMATION IS AVAILABLE AS THE PATIENT HAS NOT YET BEEN REVISED.
Patient problems: Pain; Unspecified Infection
MAUDE report 9537501 ↗InjuryJan 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THE PATIENT IS BEING CONSIDERED FOR A REVISION TO ADDRESS INFECTION AND RELATED PAIN LESS THAN A YEAR POST IMPLANTATION. NO FURTHER INFORMATION IS AVAILABLE AS THE PATIENT HAS NOT YET BEEN REVISED.
Patient problems: Pain; Unspecified Infection
MAUDE report 9537500 ↗
Other PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED devices
- DJO SURGICAL 540-00-000Encore Medical, L.P. · PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED64 reports
- 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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