BIOMET 104467 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-02-14 for BIOMET 104467 * manufactured by Biomet, Inc..

Event Text Entries

[17435101] Biomet mallory head pf femoral broach broke while broach was in the femoral canal. Osteotomy performed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4003162
• MDR Report Key: 377452
• Date Received: 2002-02-14
• Date of Report: 2002-01-18
• Date of Event: 2001-10-02
• Date Added to Maude: 2002-02-21
• 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
• 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: BIOMET
• Generic Name: MALLORY/HEAD PF RASP PROVISIONAL
• Product Code: GAC
• Date Received: 2002-02-14
• Returned To Mfg: 2001-10-02
• Model Number: 104467
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 366534
• Manufacturer: BIOMET, INC.
• Manufacturer Address: P.O. BOX 587 WARSAW IN 465810587 US
• Baseline Brand Name: MALLORY/HEAD PF RASP/PROV.
• Baseline Generic Name: RASP/PROVISIONAL
• Baseline Model No: NA
• Baseline Catalog No: 104467
• Baseline ID: NA
• Baseline Device Family: MALLORY/HEAD PF RASP PROV
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: Y

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2002-02-14