DYNASTY? COCR LINER DLCOGE40

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-23 for DYNASTY? COCR LINER DLCOGE40 manufactured by Microport Orthopedics Inc..

Event Text Entries

[186292404] Allegedly, patient was revised due to metal on metal complications.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3010536692-2020-00268
• MDR Report Key: 9869276
• Report Source: OTHER
• Date Received: 2020-03-23
• Date of Report: 2020-03-23
• Date Facility Aware: 2020-03-03
• Date Mfgr Received: 2020-03-03
• Date Added to Maude: 2020-03-23
• 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
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Street: 5677 AIRLINE ROAD
• Manufacturer City: ARLINGTON TN 38002
• Manufacturer Country: US
• Manufacturer Postal: 38002
• Manufacturer Phone: 9018674771
• Manufacturer G1: MICROPORT ORTHOPEDICS INC.
• Manufacturer Street: 5677 AIRLINE RD.
• Manufacturer City: ARLINGTON TN 38002
• Manufacturer Country: US
• Manufacturer Postal Code: 38002
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DYNASTY? COCR LINER
• Generic Name: HIP COMPONENT
• Product Code: JDL
• Date Received: 2020-03-23
• Model Number: DLCOGE40
• Catalog Number: DLCOGE40
• Lot Number: 0401096841
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MICROPORT ORTHOPEDICS INC.
• Manufacturer Address: 5677 AIRLINE RD. ARLINGTON TN 38002 US 38002

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-03-23