Zimmer® Nexel® Total Elbow 00-8400-015-07Recalls & 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
- 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 00889024271241), received between Jan 2, 2020 and May 7, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
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.
Most reported problems
Device problems
- Insufficient Device Problem Information1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Bone Fracture(s)1
- Failure of Implant1
- Fall1
- Osteopenia/ Osteoporosis1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 7, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL IMPLANTATION APPROXIMATELY THREE (3) YEARS AGO AS PART OF A CLINICAL STUDY. SUBSEQUENTLY, PATIENT HAD FALLEN AND SUFFERED A PERI-PROSTHETIC FRACTURE NEAR THE HUMERAL COMPONENT. PATIENT WAS NOT REVISED AND WAS BEING TREATED CONSERVATIVELY WITH A SPLINT. AT THE TWO (2) YEAR FOLLOW UP, THE SITE REPORTED LOOSENING OF THE HUMERAL COMPONENT AT THE SITE OF THE PERI-PROSTHETIC FRACTURE. EXAMINATION OF X-RAYS ALSO NOTED LOOSENING OF ULNAR COMPONENT. CURRENTLY, THE SITE NOTES THIS AS MILD AND TOLERATED WITH NO CURRENT PLAN FOR REVISION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Bone Fracture(s); Failure of Implant; Fall; Osteopenia/ Osteoporosis
MAUDE report 14324628 ↗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 9537491 ↗
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