MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COONRAD/MORREY TOTAL ELBOW HUMERAL COMPONENT SMALL; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).The complaint is under investigation.Once the investigation is completed a follow up mdr will be submitted.

Event Description

It was reported that the patient underwent a left elbow arthroplasty on unknown date and is now considered for a revision due to unknown reasons.No additional information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Implant date: unknown date, 2012 reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.A definite root cause cannot be determined with the information 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 approximately six (6) years post implantation, the patient is experiencing pain, and is scheduled to undergo a revision.Attempts have been made and no further information has been provided at this time.

• Brand Name: COONRAD/MORREY TOTAL ELBOW HUMERAL COMPONENT SMALL
• 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: 7826276
• MDR Text Key: 118547270
• Report Number: 0001822565-2018-04597
• Device Sequence Number: 1
• Product Code: JDB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PN/A
• 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: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 32855510811
• Device Lot Number: 95005060
• 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: 07/16/2012
• 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
• Treatment: UNKNOWN ULNAR COMPONENT
• Patient Outcome(s): Required Intervention