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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 06/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: catalog # ni, unknown elbow ulnar component, lot # ni.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2018-03460.Remains implanted.

Event Description

It was reported that a patient underwent a total elbow arthroplasty.Subsequently, the patient is being considered for a revision for an unknown reason.No further information is currently available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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 a patient underwent a total elbow arthroplasty.Subsequently, the patient was revised due to humeral loosening and pain.No further information is currently available.

• Brand Name: UNKNOWN COONRAD MORREY ELBOW HUMERAL COMPONENT
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7641639
• MDR Text Key: 112457254
• Report Number: 0001822565-2018-03459
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• 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
• Date Manufacturer Received: 06/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other