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

Model Number N/A

Device Problem Migration (4003)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/16/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical product: unknown coonrad-morrey ulnar component.The complaint is under investigation.Once the investigation is completed a follow up report will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 04656.

Event Description

It was reported that the patient underwent a revision right elbow arthroplasty, and was subsequently revised due to humeral and ulnar loosening, and ulnar peri-prosthetic fracture and bone loss approximately 2 years, 8 months post-implantation.No additional information is available.

Manufacturer Narrative

The complaint is confirmed based on the surgical operative notes that were provided.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 COONRAD-MORREY HUMERAL COMPONENT
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7812947
• MDR Text Key: 118127912
• Report Number: 0001822565-2018-04655
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• PMA/PMN Number: PNI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR