MAUDE Adverse Event Report: ZIMMER BIOMET, INC. Zimmer® Nexel® Total Elbow; Prosthesis, Elbow, Constrained, Cemented

Catalog Number	00840002411
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Osteolysis (2377); Medical device site infection (4845); Aseptic loosening (4883)
Date of Event	06/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event.Associated reports are available for the applicable concomitant products in the d10 narrative below.D10: concomitant medical products, part (lot): - 00840004410 (unknown), - unknown articulation kit (unknown), - unknown cerclage wires (unknown).G2: foreign - the event occurred in australia.Attempts have been made to gather all product identification information, and no further information has been provided.If any further information is found that would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: Zimmer® Nexel® Total Elbow
• Common Device Name: Prosthesis, Elbow, Constrained, Cemented
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 25873240
• Report Number: 0001822565-2026-02616
• Device Sequence Number: 10604263
• Product Code: JDC
• UDI-Device Identifier: 00889024271296
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/30/2025
• Device Catalogue Number: 00840002411
• Device Lot Number: 63006561
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 07/20/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male