MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXEL ARTICULATION KIT SIZE 4 1 AXLE PIN, 1 HUMERAL BEARING A, 2 ULNAR BEARINGS; PROSTHESIS, EXTREMITY

Model Number N/A

Device Problems Difficult to Advance (2920); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/19/2018

Event Type  malfunction  

Manufacturer Narrative

Multiple mdr's were filed for this event.Please see associated report(s): 0001822565 - 2018 - 05868.(b)(4).Concomitant medical products: 00840009400, articulation kit, lot# 63943945.00840004410, humeral component plasma sprayed size 4 100 mm length for cemented use only, lot # 63965679.00840002407, ulnar component plasma sprayed size 4 75 mm length right for cemented use only, lot # 64006186.00840009000, humeral screw kit 2 humeral screws, lot # 64040980.00840009000, humeral screw kit 2 humeral screws, lot # 64040980.Foreign.The event occurred in (b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

The surgeon reported the coupling mechanism had no play during implantation and took strength to insert.A second articulation kit and screws were opened and attempted for use, however the same issue occurred.The device was successfully implanted in the patient without significant delay or adverse consequence to the patient.No further information is available.

• Brand Name: NEXEL ARTICULATION KIT SIZE 4 1 AXLE PIN, 1 HUMERAL BEARING A, 2 ULNAR BEARINGS
• Type of Device: PROSTHESIS, EXTREMITY
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8138513
• MDR Text Key: 129573716
• Report Number: 0001822565-2018-06659
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00840009400
• Device Lot Number: 63916386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1