Zimmer® Nexel® Total Elbow 00-8400-024-07Recalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00889024271289), received between Nov 8, 2024 and Apr 25, 2025 — classified as 5 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (4 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-Ingrowth4
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Failure of Implant4
- Aseptic loosening2
- Pain2
- Hematoma1
- Insufficient Information1
- Osteolysis1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryApr 25, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ELBOW REVISION APPROXIMATELY ONE (1) YEAR AND THREE (3) MONTHS AGO DUE TO LOOSENING OF THE IMPLANT. SUBSEQUENTLY, THE PATIENT UNDERWENT A SECOND REVISION APPROXIMATELY SIX (6) MONTHS AGO DUE TO LOOSENING OF THE IMPLANT ONCE AGAIN.
Patient problems: Aseptic loosening; Failure of Implant
MAUDE report 21909417 ↗InjuryApr 21, 2025Loosening 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
MAUDE report 21872505 ↗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 21861361 ↗InjuryApr 17, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED FROM A CLINICAL STUDY THAT A PATIENT UNDERWENT A RIGHT ELBOW REVISION APPROXIMATELY FIVE (5) YEARS AND FIVE (5) MONTHS POST-IMPLANTATION DUE TO PAIN AND OSTEOLYSIS IDENTIFIED BY X-RAY AT THE HUMERAL YOLK, DISTAL HUMERAL STEM, AND PROXIMAL ULNAR STEM. DURING THE REVISION, THE SURGEON NOTED THAT THE HUMERAL STEM WAS GROSSLY LOOSE. THE HUMERAL STEM AND ULNAR BUSHINGS WERE REVISED, AND THE ULNAR STEM WAS LEFT IN PLACE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Aseptic loosening; Failure of Implant; Osteolysis; Pain
MAUDE report 21858189 ↗InjuryNov 8, 2024Adverse 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; Insufficient Information; Pain
MAUDE report 20639893 ↗
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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