COONRAD/MORREY CUSTOM RADIAL COMPONENT 32855510690

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2011-09-16 for COONRAD/MORREY CUSTOM RADIAL COMPONENT 32855510690 manufactured by Zimmer Inc.

Event Text Entries

[20380634] This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10

[20415840] It is reported that the pt was revised due to a fractured radial component.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1822565-2011-02095
• MDR Report Key: 2256914
• Report Source: 05,08
• Date Received: 2011-09-16
• Date of Report: 2011-05-30
• Date of Event: 2011-09-07
• Date Mfgr Received: 2011-05-30
• Device Manufacturer Date: 2010-07-01
• Date Added to Maude: 2011-09-22
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: KEVIN ESCAPULE
• Manufacturer Street: P.O. BOX 708
• Manufacturer City: WARSAW IN 465810708
• Manufacturer Country: US
• Manufacturer Postal: 465810708
• Manufacturer Phone: 8006136131
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: COONRAD/MORREY CUSTOM RADIAL COMPONENT
• Generic Name: ELBOW PROSTHESIS
• Product Code: IRE
• Date Received: 2011-09-16
• Catalog Number: 32855510690
• Lot Number: 95003036
• Device Expiration Date: 2015-07-30
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ZIMMER INC
• Manufacturer Address: P.O. BOX 708 WARSAW IN 46581070 US 46581 0708

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2011-09-16