Zimmer® Nexel® Total Elbow 00-8400-014-07Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
All models of Zimmer Nexel Total Elbow (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00889024271227), received between Jul 28, 2021 and Dec 5, 2023 — classified as 8 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (6 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
- Loosening of Implant Not Related to Bone-Ingrowth6
- Adverse Event Without Identified Device or Use Problem3
- Improper or Incorrect Procedure or Method1
- Malposition of Device1
- Unintended Movement1
Patient problems
- Failure of Implant5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Loss of Range of Motion2
- Insufficient Information1
- Nerve Damage1
- Osteolysis1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryDec 5, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 18266321 ↗InjuryOct 17, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT WAS PART OF A CLINICAL STUDY AND UNDERWENT AN INITIAL IMPLANTATION APPROXIMATELY FIVE (5) YEARS AND SEVEN (7) MONTHS AGO. DURING A FIVE (5) YEAR FOLLOW-UP VISIT, ULNAR LOOSENING WAS NOTED. THE PATIENT WAS ALSO EXPERIENCING PAIN, OSTEOLYSIS, AND LIMITED RANGE OF MOTION. THE PATIENT WILL NOT UNDERGO REVISION SURGERY. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Loss of Range of Motion; Osteolysis; Pain
MAUDE report 17954494 ↗InjuryAug 31, 2023Malposition of Device; Malposition of Device
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ELBOW SURGERY APPROXIMATELY THREE (3) WEEKS AGO. SUBSEQUENTLY, THE PATIENT WAS REVISED THE NEXT DAY DUE TO MALPOSITIONING OF THE IMPLANTS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17661965 ↗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
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Loss of Range of Motion
MAUDE report 17596393 ↗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 14852732 ↗InjuryApr 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT HAD A NERVE INJURY THAT WAS PRE-EXISTING, BUT IT WORSENED AFTER THE INITIAL LEFT ELBOW PROCEDURE. SUBSEQUENTLY, THE PATIENT UNDERWENT A NERVE GRAFTING AND NERVE REPAIR SURGERY TO ADDRESS THE ISSUE.
Patient problems: Nerve Damage
MAUDE report 14220102 ↗InjuryNov 29, 2021Adverse 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
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 12882976 ↗InjuryJul 28, 2021Improper or Incorrect Procedure or Method; Unintended Movement; Loosening of Implant Not Related to Bone-Ingrowth; Improper or Incorrect Procedure or Method; Unintended Movement; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY THREE (3) MONTHS POST-IMPLANTATION DUE TO LOOSENING CAUSED BY A BONY IMPINGEMENT AS A RESULT OF THE ORIGINAL SURGERY TECHNIQUE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12239619 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page