MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN COONRAD-MORREY ULNAR STEM; PROSTHESIS, ELBOW

Model Number N/A

Device Problems Insufficient Information (3190); Migration (4003)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Implant date - unknown date, 2003.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: 0001822565-2018-03568.Patient not yet revised.

Event Description

It was reported that the patient is being considered for elbow arthroplasty revision surgery, fifteen (15) years post implantation due to unknown reasons.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Cmp-(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: reason for revision was not provided, so event cannot be confirmed since the issue is unknown.X-ray review suggests lucency at the bone cement interface of the distal humerus and proximal ulna as well as significant lucency surrounding the prosthesis at the level of the elbow joint also the appearance could be similar to infection.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.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 is being considered for elbow arthroplasty revision surgery, fifteen (15) years post implantation due to unknown reasons.Attempts have been made and no further information has been provided.

• Brand Name: UNKNOWN COONRAD-MORREY ULNAR STEM
• 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: 7658827
• MDR Text Key: 113033054
• Report Number: 0001822565-2018-03571
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 HUMERAL STEM
• Patient Outcome(s): Hospitalization; Required Intervention