Zimmer Nexel Total ElbowRecalls & reported problems across all models
Zimmer, Inc. · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 56
- Deaths reported
- 0
- Injuries reported
- 55
- Recalls
- 0
We found 13 models of Zimmer Nexel Total Elbow by Zimmer, Inc. in the FDA's device registry (GUDID). Together they are named in 56 adverse event reports in the FDA's MAUDE database, received between Oct 21, 2019 and Jul 20, 2026 — classified as 55 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (41 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Zimmer Nexel Total Elbow problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth41
- Adverse Event Without Identified Device or Use Problem12
- Insufficient Device Problem Information5
- Material Erosion4
- Fracture3
- Unintended Movement3
- Difficult to Insert1
- Flaked1
Patient problems
- Failure of Implant31
- Pain17
- Insufficient Information9
- Unspecified Infection9
- Osteolysis8
- Aseptic loosening6
- Bone Fracture(s)5
- Loss of Range of Motion5
Zimmer Nexel Total Elbow models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Zimmer® Nexel® Total Elbow 00-8400-044-10PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED18 reports
- Zimmer® Nexel® Total Elbow 00-8400-014-07PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED8 reports
- Zimmer® Nexel® Total Elbow 00-8400-024-07PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED5 reports
- Zimmer® Nexel® Total Elbow 00-8400-025-07PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED5 reports
- Zimmer® Nexel® Total Elbow 00-8400-044-15PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED4 reports
- Zimmer® Nexel® Total Elbow 00-8400-090-00PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED4 reports
- Zimmer® Nexel® Total Elbow 00-8400-045-10PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED3 reports
- Zimmer® Nexel® Total Elbow 00-8400-014-11PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED2 reports
- Zimmer® Nexel® Total Elbow 00-8400-015-07PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED2 reports
- Zimmer® Nexel® Total Elbow 00-8400-024-11PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED2 reports
- Zimmer® Nexel® Total Elbow 00-8400-046-10PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 report
- Zimmer® Nexel® Total Elbow 00-8400-055-15PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 report
- Zimmer® Nexel® Total Elbow 00-8400-056-20PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED1 report
Recent Zimmer Nexel Total Elbow adverse event reports
The 15 most recent reports across all models, 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 25874256 ↗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 ↗InjuryJul 22, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT ARTHROPLASTY ON AND UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION SURGERY ON AN UNKNOWN DATE USING A CUSTOM VRS ULNAR IMPLANT DUE TO AN UNKNOWN REASON. ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.
Patient problems: Insufficient Information; Radiolucent Lines
MAUDE report 22564264 ↗InjuryJul 10, 2025Flaked; Flaked
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ELBOW ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT IS PLANNED TO UNDERGO A REVISION ON A DATE NOT YET SCHEDULED DUE TO POTENTIAL DELAMINATION OF THE NEXEL HUMERAL IMPLANT NOTED BY THE SURGEON IN POST-OP X-RAYS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22472149 ↗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 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 ↗InjuryApr 24, 2025Unintended 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 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 21898693 ↗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 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 21872501 ↗InjuryApr 21, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
Patient problems: Failure of Implant
MAUDE report 21872498 ↗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, 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 21860768 ↗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 21859740 ↗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 ↗InjuryFeb 18, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT HAD ELBOW SURGERY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO BONE LOSS AND LOOSENING OF THE HUMERAL STEM. THERE WAS HARM/INJURY TO THE PATIENT AS THE PATIENT HAD TO UNDERWENT ADDITIONAL SURGICAL/MEDICAL PROCEDURE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Aseptic loosening; Osteolysis
MAUDE report 21398444 ↗
Other Zimmer, Inc. products
- PERSONA364 models · 2,000 reports · 3 recalls
- Persona The Personalized Knee77 models · 1,396 reports
- PERSONA Vivacit-E285 models · 1,152 reports
- NexGen198 models · 842 reports · 4 recalls
- Affixus18 models · 1 reports · 17 recalls
- PERSONA Natural Tibia25 models · 417 reports · 2 recalls
- NexGen Legacy119 models · 319 reports · 3 recalls
- Alliance32 models · 275 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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