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

Model Number N/A

Device Problems Difficult to Remove (1528); Separation Failure (2547); Appropriate Term/Code Not Available (3191)

Patient Problems No Information (3190); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Revision took place sometime in (b)(6) 2017.Patient was implanted with device sometime in 2001.Revision took place sometime in (b)(6) 2017.Concomitant medical products: catalog # ni, unknown elbow humeral component, lot # ni.Therapy date: sometime in (b)(6) 2017.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:0 001822565 - 2017 - 08710.Product location unknown.

Event Description

It was reported that the patient underwent a total elbow arthroplasty.Subsequently, during the revision of this device the surgeon was unable to remove the ulnar component.Spacers were put in place and surgery was scheduled to be completed at a later date.No further information is available at this time.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.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 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.

• Brand Name: UNKNOWN ELBOW ULNAR COMPONENT
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7605215
• MDR Text Key: 111171095
• Report Number: 0001822565-2018-03291
• 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: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• 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: 07/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 68