SULZER *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-03-15 for SULZER * manufactured by *.

Event Text Entries

[21400162] Failed right total hip.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1021365
• MDR Report Key: 321518
• Date Received: 2001-03-15
• Date of Report: 2001-03-15
• Date of Event: 2001-02-19
• Date Added to Maude: 2001-03-22
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SULZER
• Generic Name: HIP IMPLANT
• Product Code: DJI
• Date Received: 2001-03-15
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 311058
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2001-03-15