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

Catalog Number	00840004410
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); Insufficient Information (4580)
Date of Event	01/30/2025
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): - 00840009400 (b)(6).- 00840002511 (b)(6) associated product information: - 110034355 (b)(6) - 47840103800 (b)(6) - 47225500800 (b)(6) - 00840108000 (b)(6) - 00840009400 (b)(6) - 00840009500 (b)(6) - 00840009000 (b)(6).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; d6b; d10; e1; g1; g3; g6; h1; h2; h3; h6; h10.D10: concomitant medical products, part (lot): 00840002511 (63028261).Associated product information: 00840009400 (65385845), 110034355 (ax32bf1004), 47840103800 (64401469), 47225500800 (65882521), 00840108000 (56708036), 00840009400 (65385845), 00840009500 (65337404), 00840009000 (64302321).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.
Event or Problem Description
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.Proposed annex g code: mechanical (g04) - stem.The reported event is not confirmed.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were provided related to the linked complaint and reviewed by a healthcare professional.A timeline was created for this patient.A definitive root cause cannot be determined.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: NEXEL¿ TOTAL ELBOW HUMERAL 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: 20587742
• Report Number: 0001822565-2024-03461
• Device Sequence Number: 8797402
• Product Code: JDC
• UDI-Device Identifier: 00889024271340
• UDI-Public: (01)00889024271340(17)290831(10)64290038
• 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: 2025
• 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): 04/08/2025

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: 00840004410
• Device Lot Number: 64290038
• 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; 03/27/2025
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 02/25/2025; 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2019
• 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; Other; Required Intervention
• Patient Sex: Female