MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE HUMERAL ASSEMBLY EXTRA SMALL; PROSTHESIS, ELBOW

Model Number N/A

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient underwent a total elbow arthroplasty.Following the opening of the package it was noticed that in the 4¿ extra small humeral component kit the poly bush was missing from the package.When the surgeon noticed the poly bush missing, the humeral component has been already implanted, and the cement had hardened.To complete the surgery, the surgeon had to open a 4¿ small humeral component kit to take the poly bush.The surgeon then assembled it with the implanted humeral and ulna components.The size mismatch (small and extra small) was resolved by trimming off the poly bush.The event resulted in a 10 minute delay.No patient impact.

Manufacturer Narrative

(b)(4).Recall has been reported, however correction/removal reporting number has not been received to date.The reported event was confirmed through investigation of the reported event.No products were returned; therefore, the visual and dimensional inspections were not performed.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause can not be determined at this time, however actions are in place, and device is involved in reported recall.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.

Manufacturer Narrative

(b)(4).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: COONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE HUMERAL ASSEMBLY EXTRA SMALL
• Type of Device: PROSTHESIS, ELBOW
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7099710
• MDR Text Key: 94545939
• Report Number: 0001822565-2017-08260
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: PK001989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 32810502704
• Device Lot Number: 63694912
• Other Device ID Number: (01)00889024274006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1