IOMET *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-07-07 for IOMET * manufactured by Biomet, Inc..

Event Text Entries

[127451] One biomet acetabular inserter broke during use. All pieces were recovered.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1016703
• MDR Report Key: 231150
• Date Received: 1999-07-07
• Date of Report: 1999-04-29
• Date of Event: 1999-04-09
• Date Added to Maude: 1999-07-13
• 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: IOMET
• Generic Name: ACETABULAR INSERTER
• Product Code: HXO
• Date Received: 1999-07-07
• Returned To Mfg: 1999-05-01
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 224066
• Manufacturer: BIOMET, INC.
• Manufacturer Address: AIRPORT INDUSTRIAL PARK WARSAW IN 46580 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1999-07-07