BIOMET * 162910

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 * 162910 manufactured by Biomet - Holzbach.

Event Text Entries

[252659] Infection following joint replacement (right hip).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 428054
• MDR Report Key: 428054
• Date Received: 2002-11-13
• Date of Report: 2002-11-12
• Date of Event: 2002-10-17
• 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/FEMORAL CENTERING SLEEVE
• Product Code: JDI
• Date Received: 2002-11-13
• Model Number: *
• Catalog Number: 162910
• Lot Number: 603790
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 417079
• Manufacturer: BIOMET - HOLZBACH
• Manufacturer Address: 2575 HOMEVIEW DRIVE RICHMOND VA 23294 US

Device Sequence Number: 2

• Brand Name: BIOMET
• Generic Name: MODULAR HEAD COMPONENT
• Product Code: JDD
• Date Received: 2002-11-13
• Model Number: *
• Catalog Number: 163663
• Lot Number: 164850
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 417084
• Manufacturer: BIOMET - HOLZBACH
• Manufacturer Address: 2575 HOMEVIEW DRIVE RICHMOND VA 23294 US

Device Sequence Number: 3

• Brand Name: BIOMET
• Generic Name: RING LOC ACETABULAR LINER
• Product Code: KWB
• Date Received: 2002-11-13
• Model Number: *
• Catalog Number: 11-105913
• Lot Number: 152710
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 417085
• Manufacturer: BIOMET - HOLZBACH
• Manufacturer Address: 2575 HOMEVIEW DRIVE RICHMOND VA 23294 US

Device Sequence Number: 4

• Brand Name: BIOMET
• Generic Name: HIP FRACTURE FEMORAL
• Product Code: JDD
• Date Received: 2002-11-13
• Model Number: *
• Catalog Number: 162901
• Lot Number: 591350
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 4
• Device Event Key: 417087
• Manufacturer: BIOMET - HOLZBACH
• Manufacturer Address: 2575 HOMEVIEW DRIVE RICHMOND VA 23294 US

Device Sequence Number: 5

• Brand Name: BIOMET
• Generic Name: HEMISPHERICAL ACTBIR. W/PLUG
• Product Code: KWB
• Date Received: 2002-11-13
• Model Number: *
• Catalog Number: 14-104052
• Lot Number: 583330
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 5
• Device Event Key: 417088
• Manufacturer: BIOMET - HOLZBACH
• Manufacturer Address: 2575 HOMEVIEW DRIVE RICHMOND VA 23294 US

Device Sequence Number: 6

• Brand Name: BIOMET
• Generic Name: HIP PREPARATION KIT
• Product Code: JDI
• Date Received: 2002-11-13
• Model Number: *
• Catalog Number: 424700
• Lot Number: M 203864
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 6
• Device Event Key: 417089
• Manufacturer: BIOMET - HOLZBACH
• Manufacturer Address: 2575 HOMEVIEW DRIVE RICHMOND VA 23294 US

Device Sequence Number: 7

• Brand Name: BIOMET
• Generic Name: INTRAMULLARY BONE PLUG
• Product Code: MJW
• Date Received: 2002-11-13
• Model Number: *
• Catalog Number: 130613
• Lot Number: 565770
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 7
• Device Event Key: 417091
• Manufacturer: BIOMET - HOLZBACH
• Manufacturer Address: 2575 HOMEVIEW DRIVE RICHMOND VA 23294 US

Device Sequence Number: 8

• Brand Name: BIOMET
• Generic Name: BONE CEMENT
• Product Code: LOD
• Date Received: 2002-11-13
• Model Number: *
• Catalog Number: 424800
• Lot Number: 201 9517
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 8
• Device Event Key: 417093
• 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: 9

• Brand Name: LIQUID
• Generic Name: BONE CEMENT LIQUID
• Product Code: LOD
• Date Received: 2002-11-13
• Model Number: *
• Catalog Number: *
• Lot Number: 3166
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 9
• Device Event Key: 417095
• 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