BIOMET * 424700

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-11-13 for BIOMET * 424700 manufactured by Biomet - Holzbach.

Event Text Entries

[18196134] Infection following joint replacement (left hip).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	428023
MDR Report Key	428023
Date Received	2002-11-13
Date of Report	2002-11-12
Date of Event	2002-10-15
Date Facility Aware	2002-11-06
Report Date	2002-11-12
Date Reported to FDA	2002-11-12
Date Reported to Mfgr	2002-11-12
Date Added to Maude	2002-11-19
Event Key	0
Report Source Code	User Facility 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	3
Report to FDA	3
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Sequence Number: 1

Brand Name	BIOMET
Generic Name	JOINT IMPLANT/HIP PREPARATION KIT
Product Code	KDD
Date Received	2002-11-13
Model Number	*
Catalog Number	424700
Lot Number	202577
ID Number	*
Operator	HEALTH PROFESSIONAL
Device Availability	N
Device Age	*
Implant Flag	Y
Date Removed	*
Device Sequence No	1
Device Event Key	417044
Manufacturer	BIOMET - HOLZBACH
Manufacturer Address	2575 HOMEVIEW DRIVE RICHMOND VA 23294 US
Baseline Brand Name	HIP PREP KIT
Baseline Generic Name	DISPOSABLE INSTRUMENT KIT
Baseline Model No	NA
Baseline Catalog No	424700
Baseline ID	NA
Baseline Device Family	HIP PREP KIT
Baseline Shelf Life Contained	N
Baseline Shelf Life [Months]	120
Baseline PMA Flag	N
Baseline 510K PMN	N
Baseline Preamendment	N
Baseline Transitional	N
510k Exempt	Y

Device Sequence Number: 2

Brand Name	BIOMET
Generic Name	MODULER HEAD COMPONENT
Product Code	KWA
Date Received	2002-11-13
Model Number	*
Catalog Number	11-173660
Lot Number	698740
ID Number	*
Operator	HEALTH PROFESSIONAL
Device Availability	N
Device Age	*
Implant Flag	Y
Date Removed	*
Device Sequence No	2
Device Event Key	417045
Manufacturer	BIOMET - HOLZBACH
Manufacturer Address	2575 HOMEVIEW DRIVE RICHMOND VA 23294 US
Baseline Brand Name	M2A MODULAR HEAD
Baseline Generic Name	PROSTHESIS, HIP, COMP
Baseline Model No	NA
Baseline Catalog No	11-173660
Baseline ID	NA
Baseline Device Family	M2A MODULAR HEAD
Baseline Shelf Life Contained	Y
Baseline Shelf Life [Months]	120
Baseline PMA Flag	N
Baseline 510K PMN	Y
Premarket Notification	K011110
Baseline Preamendment	N
Baseline Transitional	N
510k Exempt	N

Device Sequence Number: 3

Brand Name	BIOMET
Generic Name	INTERAL CENTRALIZER FEMORAL
Product Code	LPH
Date Received	2002-11-13
Model Number	*
Catalog Number	12-162609
Lot Number	427840
ID Number	*
Operator	HEALTH PROFESSIONAL
Device Availability	N
Device Age	*
Implant Flag	Y
Date Removed	*
Device Sequence No	3
Device Event Key	417046
Manufacturer	BIOMET - HOLZBACH
Manufacturer Address	2575 HOMEVIEW DRIVE RICHMOND VA 23294 US
Baseline Brand Name	INTEGRAL LATERALIZED POROUS FMRL
Baseline Generic Name	PROSTHESIS, HIP, COMP
Baseline Model No	NA
Baseline Catalog No	11-162609
Baseline ID	NA
Baseline Device Family	INTEGRAL LATERALIZED POROUS FMRL
Baseline Shelf Life Contained	Y
Baseline Shelf Life [Months]	120
Baseline PMA Flag	N
Baseline 510K PMN	Y
Premarket Notification	K984296
Baseline Preamendment	N
Baseline Transitional	N
510k Exempt	N

Device Sequence Number: 4

Brand Name	BIOMET
Generic Name	INTEGAL/IMPACT/ANSWER
Product Code	JDG
Date Received	2002-11-13
Model Number	*
Catalog Number	162656
Lot Number	572860
ID Number	*
Operator	HEALTH PROFESSIONAL
Device Availability	N
Device Age	*
Implant Flag	Y
Date Removed	*
Device Sequence No	4
Device Event Key	417047
Manufacturer	BIOMET - HOLZBACH
Manufacturer Address	2575 HOMEVIEW DRIVE RICHMOND VA 23294 US
Baseline Brand Name	INTEGRAL/IMPACT/ANSWER DSTL PSTNR
Baseline Generic Name	PROSTHESIS, HIP, COMP
Baseline Model No	NA
Baseline Catalog No	162656
Baseline ID	NA
Baseline Device Family	INTEGRAL/IMPACT/ANSWER DSTL PSTNR
Baseline Shelf Life Contained	Y
Baseline Shelf Life [Months]	120
Baseline PMA Flag	N
Baseline 510K PMN	Y
Premarket Notification	K942479
Baseline Preamendment	N
Baseline Transitional	N
510k Exempt	N

Device Sequence Number: 5

Brand Name	BIOMET
Generic Name	INTRAMULLARY BONE PLUG
Product Code	MJW
Date Received	2002-11-13
Model Number	*
Catalog Number	130611
Lot Number	133930
ID Number	*
Operator	HEALTH PROFESSIONAL
Device Availability	*
Device Age	*
Implant Flag	Y
Date Removed	*
Device Sequence No	5
Device Event Key	417048
Manufacturer	BIOMET - HOLZBACH
Manufacturer Address	2575 HOMEVIEW DRIVE RICHMOND VA 23294 US

Device Sequence Number: 6

Brand Name	BIOMET
Generic Name	BONE CEMENT
Product Code	LOD
Date Received	2002-11-13
Model Number	*
Catalog Number	424800
Lot Number	211 9607
ID Number	*
Operator	HEALTH PROFESSIONAL
Device Availability	N
Device Age	*
Implant Flag	Y
Date Removed	*
Device Sequence No	6
Device Event Key	417049
Manufacturer	BIOMET - HOLZBACH
Manufacturer Address	2575 HOMEVIEW DRIVE RICHMOND VA 23294 US
Baseline Brand Name	PALACOS BONE CEMENT
Baseline Generic Name	BONE CEMENT
Baseline Model No	NA
Baseline Catalog No	424800
Baseline ID	NA
Baseline Device Family	PALACOS BONE CEMENT
Baseline Shelf Life Contained	Y
Baseline Shelf Life [Months]	60
Baseline PMA Flag	Y
Premarket Approval	P8100
Baseline 510K PMN	N
Baseline Preamendment	N
Baseline Transitional	N
510k Exempt	N

Device Sequence Number: 7

Brand Name	LIQUID
Generic Name	BONE CEMENT LIQUID
Product Code	LOD
Date Received	2002-11-13
Model Number	*
Catalog Number	*
Lot Number	3340
ID Number	*
Operator	HEALTH PROFESSIONAL
Device Availability	N
Device Age	*
Implant Flag	Y
Date Removed	*
Device Sequence No	7
Device Event Key	417051
Manufacturer	BIOMET - HOLZBACH
Manufacturer Address	2575 HOMEVIEW DRIVE RICHMOND VA 23294 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening; 2. Required No Informationntervention	2002-11-13