MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN ULNAR COMPONENT; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Pain (1994)

Event Date 06/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6) customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Unique identifier (udi) #: n/a.Concomitant medical products: unknown humeral component.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 01823.

Event Description

It was reported by a patient that they had underwent a left elbow revision approximately 12 years post initial implantation due to unknown reasons.The patient alleged that when they had left the hospital post revision, the wound was left open, and had developed pain and infection as well.Attempts for further information have been made, and none has been provided.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the part and lot number of the device involved in the event was not accurately provided.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 report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: UNKNOWN ULNAR COMPONENT
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8575518
• MDR Text Key: 143890979
• Report Number: 0001822565-2019-01824
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 57