MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXEL ARTICULATION KIT SIZE 5/6; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Migration (4003)

Patient Problem Tissue Damage (2104)

Event Date 10/18/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 00840002411 ulnar component plasma sprayed size 4 115 mm length right for cemented use only 63095903 00111314001 palacos rg 1x40 single 89904771 - qty 2, 211266 compr srs anti rot ic seg-30mm 351820, 110029939 compr srs 60mm dst hum bdy rt 588380, 211269 compr srs small flange 155830, 211230 compr srs mod stem -6x75mm 36590, 00111914001 palacos lvg 1x40 single 87014599.Customer has indicated that the product was not returned by the hospital.Once the investigation is completed a follow up report will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 00748, 0001822565 - 2019 - 00756, 0001822565 - 2019 - 00754, 0001822565-2019-00766.

Event Description

It was reported that the patient underwent a revision surgery for the elbow and was subsequently revised for loosening and wound site complication (implant broke through the skin) two weeks post implantation.No additional information is available at this time.

Event Description

No additional information is available to report.

Manufacturer Narrative

The follow up report is being submitted to relay additional information received the complaint cannot be confirmed as no medical records were provided from the event.However it is stated that during this procedure since the patient had very little bone left the surgeon elected for off label use of the ulna component and implanted that component into the radius so he could reconstruct something.Patient had history of nonhealing, infection, multiple elbow traumas & surgeries.Per the 97-8401-002-00 rev.1 the ulnar component was intended to be implanted into ulna.Review of the device history records identified no related deviations or anomalies.The root cause of the reported issue is attributed to use error.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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.

• Brand Name: NEXEL ARTICULATION KIT SIZE 5/6
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8348515
• MDR Text Key: 136502842
• Report Number: 0001822565-2019-00678
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: K123862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/21/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00840009500
• Device Lot Number: 63785438
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/21/2019
• Initial Date FDA Received: 02/18/2019
• Supplement Dates Manufacturer Received: 06/17/2019
• Supplement Dates FDA Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention