Zimmer® Nexel® Total Elbow 00-8400-044-10Recalls & 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
- 18
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00889024271340), received between Oct 21, 2019 and Jul 20, 2026 — classified as 17 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (14 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-Ingrowth14
- Adverse Event Without Identified Device or Use Problem3
- Difficult to Insert1
- Insufficient Device Problem Information1
- Loss of or Failure to Bond1
- Peeled/Delaminated1
- Use of Device Problem1
Patient problems
- Failure of Implant9
- Pain5
- Osteolysis4
- Aseptic loosening3
- Unspecified Infection3
- Bone Fracture(s)2
- Insufficient Information2
- Loss of Range of Motion2
Recent adverse event reports
The 18 most recent of 18 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 25874256 ↗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 ↗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 ↗InjuryFeb 18, 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 EVENT IS A DUPLICATE TO 0001822565-2025-00375. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.
Patient problems: Osteolysis
MAUDE report 21396090 ↗InjuryNov 25, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THROUGH A CLINICAL STUDY, THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL ELBOW ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS EVALUATED DUE TO PERSISTENT PAIN AND LIMITED RANGE OF MOTION. RADIOGRAPHIC IMAGING DEMONSTRATES HUMERAL COMPONENT LOOSENING. THE PATIENT IS INDICATED TO UNDERGO A FUTURE REVISION; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE.
Patient problems: Failure of Implant; Loss of Range of Motion; Pain
MAUDE report 20774074 ↗InjuryNov 1, 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
IT WAS REPORTED THAT A PATIENT IS CONSIDERING AN ELBOW REVISION PROCEDURE DUE TO UNKNOWN REASONS TO REMOVE THE HUMERAL STEM IMPLANTED APPROXIMATELY FOUR (4) YEARS AGO AND OTHER ELBOW COMPONENTS IMPLANTED APPROXIMATELY ONE AND A HALF (1.5) YEARS AGO. THIS PLANNED REVISION WILL INVOLVE REPLACEMENTS WITH COMPETITOR PRODUCTS ON AN UNKNOWN DATE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Insufficient Information
MAUDE report 20587742 ↗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 19371436 ↗InjuryDec 5, 2023Loosening 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; Insufficient Information
MAUDE report 18266323 ↗InjuryJun 16, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant
MAUDE report 17142531 ↗MalfunctionFeb 24, 2023Difficult to Insert; Difficult to Insert
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16434957 ↗InjuryAug 10, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL ELBOW ARTHROPLASTY AND WAS SUBSEQUENTLY REVISED DUE TO HUMERAL COMPONENT LOOSENING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
Patient problems: Failure of Implant
MAUDE report 15197780 ↗InjuryApr 28, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT TO RIGHT TOTAL ELBOW ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT IS EXPERIENCING SEVERE PAIN, DISCOMFORT AND UNABLE TO LIFT ARM. THE RADIOGRAPHIC ASSESSMENT REVEALED AN ULNAR COMPONENT LOOSENING AT THE SIX AND NINE MONTH FOLLOW UPS. THE RADIOGRAPHIC ASSESSMENT FURTHER REVEALED A HUMERAL LOOSENING AT THE NINE MONTH FOLLOW UP. PROGRESSION OF LOOSENING WITH RISK OF PERIPROSTHETIC FRACTURE REPORTED DURING 3-YEAR FOLLOW UP FOR BOTH HUMERAL AND ULNAR COMPONENTS. A REVISION PROCEDURE HAS BEEN INDICATED BUT NOT YET SCHEDULED.
Patient problems: Bone Fracture(s); Loss of Range of Motion; Osteopenia/ Osteoporosis; Pain
MAUDE report 14237536 ↗InjuryNov 29, 2021Use of Device Problem; Loosening of Implant Not Related to Bone-Ingrowth; Use of Device Problem; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 12883031 ↗InjuryNov 24, 2021Peeled/Delaminated; Loosening of Implant Not Related to Bone-Ingrowth; Peeled/Delaminated; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Osteopenia/ Osteoporosis; Pain
MAUDE report 12869906 ↗InjuryMar 12, 2021Adverse 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 ADDITIONAL EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Unspecified Infection
MAUDE report 11474958 ↗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 9537487 ↗InjuryOct 21, 2019Loss of or Failure to Bond; Loss of or Failure to Bond
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Discomfort
MAUDE report 9215371 ↗
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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