MAUDE Adverse Event Report: TURPEAUX INDUSTRIAL PARK COONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE ULNAR ASSEMBLY; JDC

Model Number N/A

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Information (3190)

Event Date 06/23/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported a patient will be revised due to loosening.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

No device or photos were received; therefore the condition of the component is unknown.Review of the device history records did not find any deviations or anomalies.This device is used for treatment.It is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.The implants were in vivo for more than 2 years.Product history search revealed no additional complaints against the related part and lot combination.A definite root cause cannot be determined with the information provided.

Event Description

It is reported the patient's elbow arthroplasty was revised due to loosening.

• Brand Name: COONRAD/MORREY TOTAL ELBOW INTERCHANGEABLE ULNAR ASSEMBLY
• Type of Device: JDC
• Manufacturer (Section D): TURPEAUX INDUSTRIAL PARK; rt. #1, km 123.4; bldg. #1; mercedita PR 00715
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5554728
• MDR Text Key: 42073447
• Report Number: 1822565-2016-00967
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2015
• Device Model Number: N/A
• Device Catalogue Number: 32810509301
• Device Lot Number: 61507490
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/21/2016
• Initial Date FDA Received: 04/07/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/04/2016; 08/02/2016; 08/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2010
• 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
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Weight: 69