MAUDE Adverse Event Report: ZIMMER BIOMET, INC. INTERCHANGEABLE HUMERAL ASSEMBLY; ELBOW PROSTHESIS

Catalog Number 32810502504

Device Problems Loss of or Failure to Bond (1068); Fracture (1260); Malposition of Device (2616); Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 32810505302 interchangeable ulnar assembly 61097162; cement, bone surgical simplex p mlro76; restrictor, cement reality 10mm k12315.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.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: 0001822565-2019-04479.

Event Description

It was reported that the patient underwent an initial right elbow arthroplasty.Subsequently, the patient is planned to be revised due to unknown reason.No revision has been reported to date.No additional patient consequences were reported.

Event Description

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

Manufacturer Narrative

Reported event was confirmed by review of radiographs.Review of the available radiographs identified: right elbow arthroplasty with significant loosening of the humeral component as well as possible bony fracture of the distal humerus.Loosening is identified involving the humeral component with associated malalignment.No dislocation.Bony resection of the coronoid process also seen.Device history record (dhr) was reviewed and no discrepancies were found.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

The patient is being planned to revise due to humeral component loosening and fracture.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: INTERCHANGEABLE HUMERAL ASSEMBLY
• Type of Device: ELBOW PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9217777
• MDR Text Key: 163149634
• Report Number: 0001822565-2019-04480
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• PMA/PMN Number: K181307
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Catalogue Number: 32810502504
• Device Lot Number: 61405602
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention