MAUDE Adverse Event Report: . COONRAD/MORREY INTERCHANGEABLE ULNAR ASSEMBLY; PROSTHESIS, ELBOW

Model Number N/A

Device Problems Malposition of Device (2616); Migration (4003)

Patient Problem Unspecified Infection (1930)

Event Date 08/09/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 32810502504, interchangeable humeral assembly for cemented use only small, 63694882.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565- 2018 - 04926.Product location unknown.

Event Description

It was reported that the patient underwent a right initial elbow arthroplasty and was revised due to loosening, malposition and possible infection with in one year post implantation.Attempts to obtain additional information have been made; however, no more is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of x-rays provided.X-ray determined lucency along the radial aspect of the humeral component at the cement hardware interface distally near the joint.No definite evidence for lucency along the ulnar component.Device history record 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

It was reported that the patient underwent a right initial elbow arthoplasty and was revised due to loosening, malposition and possible infection with in one year post implantation.Attempts to obtain additional information have been made; however, no more is available at this time.

• Brand Name: COONRAD/MORREY INTERCHANGEABLE ULNAR ASSEMBLY
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): .; 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: 7875617
• MDR Text Key: 120240637
• Report Number: 0001822565-2018-04923
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 32810505302
• Device Lot Number: 62897326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2015
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR