MAUDE Adverse Event Report: ZIMMER, INC. ZIMMER NEXEL VIVACIT-E HIGHLY CROSSLINKED POLYETHYLENE ARTICULATION KIT; ELBOW PROSTHESIS

Catalog Number 00840009400

Device Problem Component Incompatible (1108)

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

Event Date 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Concomitant medical products: catalog #00840004410, zimmer nexel plasma sprayed humeral component, lot #63313335; catalog #00840001407, zimmer nexel plasma sprayed ulnar component, lot #63169548.

Event Description

It was reported that the axle pin and ulnar bearings were not able to be assembled with the ulnar component during elbow arthroplasty.No further information is available.

Manufacturer Narrative

This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.No devices or photos were returned for evaluation.The device history records were reviewed for the pin and bearings with no deviations or anomalies being identified.This device is used for treatment.The complaint history review was conducted for the devices and found no additional complaints for the same lots.Surgical technique and notes were not provided.A definitive root cause of the reported issue cannot be determined with the information provided.

Manufacturer Narrative

This follow up report is being submitted to relay additional information.Dhr was reviewed and no discrepancies relevant to the reported event were found.The complaint sample was evaluated and the reported event could not be confirmed as no issues were identified.The articulation kit was received and the axle pin and ulnar bearings were able to assemble with the ulna component, contradictory to the reported event.A root cause was unable to be determined as device analysis indicated that the device met specification and the complaint could not be substantiated.

• Brand Name: ZIMMER NEXEL VIVACIT-E HIGHLY CROSSLINKED POLYETHYLENE ARTICULATION KIT
• Type of Device: ELBOW PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6210345
• MDR Text Key: 63431272
• Report Number: 0001822565-2016-04806
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK123862
• 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,Followup,Followup
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 00840009400
• Device Lot Number: 63076176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1