MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE HUMERAL ASSEMBLY PROSTHESIS ELBOW

Model Number N/A

Device Problem Component Missing (2306)

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

Event Date 11/08/2017

Event Type  malfunction  

Manufacturer Narrative

Reported event was able to be confirmed via complaint history review. Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found. A definite root cause has not yet been determined, however, remedial action has been initiated. No correction//removal number has been received. 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.

Manufacturer Narrative

(b)(4). (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation as it remains implanted in the patient. Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during a surgery, the surgeon found the poly bushing missing from a brand new humeral component package. The surgery was completed with a poly bush from another package. No adverse events have been reported as a result of the malfunction.

• Brand Name: COONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE HUMERAL ASSEMBLY
• Type of Device: PROSTHESIS ELBOW
• 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: 7104200
• MDR Text Key: 253866805
• Report Number: 0001822565-2017-08337
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: PK001989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr

Reporter Occupation

• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/21/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 32810502704
• Device Lot Number: 63694912
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2017
• 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