MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXEL¿ TOTAL ELBOW ULNAR COMPONENT PLASMA SPRAYED; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Catalog Number	00840002407
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Insufficient Information (4580)
Date of Event	05/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an elbow revision procedure approximately three and a half (3.5) years post-implantation.The articulation kit, ulnar component, and humeral screws were replaced during this revision due to unknown reasons, which occurred approximately one and a half (1.5) years ago.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 below in the d10 narrative.D10: concomitant medical products, part (lot): - 00840009400 (64295459) associated product information: - 00840009000 (64302321) - 110034355 (835aae2507) the customer has not indicated whether the product will be zimmer biomet for investigation, and the product location is unknown.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 a patient had a right total elbow arthroplasty approximately five (5) years ago.Subsequently, developed significant pain and underwent a revision approximately forty-one (41) months later due to loosening.The cemented humeral component remained implanted while the cemented ulna, humeral screws, and articulation kit were all revised without complication.No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b1; b4; b5; b7; d2; d10; e1; g1; g3; g6; h1; h2; h3; h6.D10: associated product information, part (lot): 00840009000 (64302321) , 110034355 (835aae2507), 00840009400 (64295459).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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6.H6: proposed annex g code: mechanical (g04) - stem.The reported event is confirmed based upon medical records.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided and reviewed by a healthcare professional.Review of the available records identified the following in the operative report: mechanical failure of ulnar component in a previously revised elbow, history of muscle flap overlying elbow, significant pain, and cement allergy.General anesthesia.Surgical incision in posterior aspect utilized.Muscle flap in place overlying direct approach, therefore, came around medially to elevate the muscle flap without damaging the vascular pedicle.Ulnar component grossly loose.Absence of the olecranon.3rd generation cement technique used.Muscle flap closed in a layered fashion, no intra-op complications/events.A definitive root cause cannot be determined.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
No further event information is available at the time of this report.

• Brand Name: NEXEL¿ TOTAL ELBOW ULNAR COMPONENT PLASMA SPRAYED
• 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: 20639893
• Report Number: 0001822565-2024-03506
• Device Sequence Number: 20709494
• Product Code: JDC
• UDI-Device Identifier: 00889024271289
• UDI-Public: (01)00889024271289(17)290630(10)64264471
• 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: 2019
• Device Explanted 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,Followup
• Report Date (Section B): 03/18/2025

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: 00840002407
• Device Lot Number: 64264471
• 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: 10/14/2024
• Supplement Date Received by Manufacturer: 01/31/2025; 03/11/2025
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 02/25/2025; 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Hospitalization; Required Intervention
• Patient Sex: Female