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

Catalog Number	00840002507
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event.Please see the associated reports referenced with applicable concomitant products below in the d10 narrative.D10: concomitant medical products, part (lot): - 00840004410 (63213288).G2: foreign - the event occurred in new zealand.The customer has indicated that the product will not be returned to zimmer biomet for investigation.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 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.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: b4; b5; b7; d2; g1; g3; g6; h1; h2; h3; h6; h10.H6: proposed annex g code - mechanical (g04) stem.The reported event is confirmed based upon the mmi review.No product was returned, and no pictures were provided, so 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.Radiographs were provided and reviewed by a healthcare professional.A review of the available records identified the following: a hinged elbow arthroplasty is in place.There is a fracture of the mid-ulnar diaphysis with extensive radiolucency along the ulnar implant, reflecting osteolysis and implant loosening.The humeral implant is also loose with prominent radiolucency along the cement-bone interface.Large cement fragments are noted laterally.The proximal radius is displaced superiorly.There is soft tissue swelling and evidence of muscle atrophy.Bone quality is osteopenic.The root cause of the reported issue is attributed to patient non-compliance.Per the ifu, "the patient must be instructed about all postoperative restrictions, particularly those related to occupational and sports activities, and about the possibility that the implant or its components may wear out, fail or need to be replaced." a summary of the investigation was not sent as the surgeon was aware of the patient's noncompliance.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 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.

• Brand Name: ZIMMER NEXEL TOTAL ELBOW ULNAR COMPONENT
• 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: 19371445
• Report Number: 0001822565-2024-01695
• Device Sequence Number: 7510195
• Product Code: JDC
• UDI-Device Identifier: 00889024271302
• UDI-Public: (01)00889024271302(17)251130(10)63158778
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K181307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2024

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: Health Professional
• Device Expiration Date: 11/30/2025
• Device Catalogue Number: 00840002507
• Device Lot Number: 63158778
• 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: 04/26/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2015
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown
• Patient Weight: 101 KG