Zimmer® Nexel® Total Elbow 00-8400-025-07Recalls & 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 00889024271302), received between Aug 25, 2022 and Nov 15, 2024 — 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 Problem1
- Material Erosion1
- Unintended Movement1
Patient problems
- Failure of Implant3
- Pain3
- Bone Fracture(s)1
- High metal ion levels1
- Muscle/Tendon Damage1
- Osteolysis1
- Radiolucent Lines1
- Tissue Breakdown1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
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 20695616 ↗InjuryMay 22, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ELBOW PROCEDURE THAT REQUIRED REVISION APPROXIMATELY SEVEN (7) YEARS LATER DUE TO AN ULNA FRACTURE AND LOOSENING OF THE HUMERAL COMPONENT. THE PRODUCTS WERE SUCCESSFULLY REMOVED AND REPLACED WITH A COMPETITOR PRODUCT. THE SURGEON REMARKED THAT THIS EVENT WAS NOT LINKED TO IMPLANT FAILURE AND THAT IT WAS LIKELY A RESULT OF PATIENT NONCOMPLIANCE AND POOR BONE QUALITY. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Bone Fracture(s)
MAUDE report 19371445 ↗InjuryNov 7, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
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 18083779 ↗InjurySep 6, 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
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SECOND REVISION APPROXIMATELY ONE YEAR LATER DUE TO PAIN, LOOSENING OF THE ULNA COMPONENT, AND TRICEPS TENDON RUPTURE IN THE RIGHT ELBOW. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
Patient problems: Failure of Implant; Muscle/Tendon Damage; Pain
MAUDE report 17689870 ↗InjuryAug 25, 2022Unintended Movement; Loosening of Implant Not Related to Bone-Ingrowth; Unintended Movement; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT ELBOW PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO PAIN, LOOSENING AND IMPINGEMENT APPROXIMATELY AFTER SIX YEARS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Failure of Implant; Pain; Tissue Breakdown
MAUDE report 15293171 ↗
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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