MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXEL¿ VIVACIT-E® TOTAL ELBOW HIGHLY CROSSLINKED POLYETHYLENE ARTICULATION KIT; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Catalog Number	00840009400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event.Associated reports are available for the applicable concomitant products below in the d10 narrative.D10: concomitant medical products, part (lot): - 00840002511 (63028261) - 00840004410 (64290038) associated product information: - 110034355 (ax32bf1004) - 47840103800 (64401469) - 47225500800 (65882521) - 00840108000 (56708036) - 00840009400 (65385845) - 00840009500 (65337404) - 00840009000 (64302321) the customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.
Event or Problem Description
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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b1; b2; b4; b5; b7; d2; g1; g3; g6; h1; h2; h3; h10.Upon reassessment of the reported event, it was determined to be not reportable as this device did not contribute to the reported event.The initial report was submitted in error and should be voided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported a patient had a right total elbow arthroplasty approximately five (5) years ago followed by a revision forty-one (41) months later due to pain and ulnar loosening.Subsequently, one (1) month ago, the patient underwent a second revision due loosening of the ulnar and humeral implants.A competitor, custom made, ulnar implant and a zb humeral implant were placed.No further event information is available at the time of this report.

• Brand Name: NEXEL¿ VIVACIT-E® TOTAL ELBOW HIGHLY CROSSLINKED POLYETHYLENE ARTICULATION KIT
• 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: 20587676
• Report Number: 0001822565-2024-03459
• Device Sequence Number: 8788126
• Product Code: JDC
• UDI-Device Identifier: 00889024271456
• UDI-Public: (01)00889024271456(17)271106(10)65385845
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K181307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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 Catalogue Number: 00840009400
• Device Lot Number: 65385845
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2022
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Sex: Female