Zimmer® Nexel® Total Elbow 00-8400-024-11Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024271296), received between Apr 24, 2025 and Jul 20, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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
- Loosening of Implant Not Related to Bone-Ingrowth2
Patient problems
- Aseptic loosening1
- Failure of Implant1
- Joint Laxity1
- Medical device site infection1
- Osteolysis1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 20, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A PATIENT UNDERWENT A SECOND RIGHT TOTAL ELBOW REVISION DUE TO INFECTION, LOOSENING, AND LYSIS. THE PATIENT HAD PREVIOUSLY UNDERGONE AN INITIAL RIGHT TOTAL ELBOW ARTHROPLASTY ON AN UNKNOWN DATE. THE PATIENT WAS SUBSEQUENTLY REVISED FOR THE FIRST TIME. DURING THE FIRST REVISION, EXTENSIVE METALLOSIS WAS NOTED, ASSOCIATED WITH A FAILED CENTRAL PIN AND BEARING WEAR. THE HUMERAL AND ULNA IMPLANTS WERE WELL FIXED AT THAT TIME. ALL IMPLANTS WERE REVISED WITHOUT COMPLICATIONS. APPROXIMATELY SIX YEARS AND NINE MONTHS AFTER THE FIRST REVISION, THE PATIENT UNDERWENT A SECOND REVISION DUE TO INFECTION, LOOSENING, AND LYSIS. DELAMINATION OF THE HUMERAL COMPONENT WAS REPORTED. THE PATIENT UNDERWENT REVISION SURGERY. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Aseptic loosening; Medical device site infection; Osteolysis
MAUDE report 25873240 ↗InjuryApr 24, 2025Loosening of Implant Not Related to Bone-Ingrowth; 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 21898695 ↗
Other PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED devices
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- 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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