LT TOTAL KNEE PROSTHESIS X *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-04-30 for LT TOTAL KNEE PROSTHESIS X * manufactured by Biomet, Inc..

Event Text Entries

[273282] Pt admitted with diagnosis of loose lt total knee prosthesis. The pt had a long complex problem involving their knees. In 1982 pt underwent lt total knee arthroplasty, afterward suffered persistent staph infection. In 1992, pt underwent revision then after developed serratia of marcescens, required removal of prosthesis in 1998 and 8-10 wks if antibiotics. Five months later pt underwent revision with a thin rotating hinge prosthesis. The pt did initially well but started to have more pain and instability. Pt's pain was located in the region of the thigh requiring a walker to ambulate. In 2002, pt underwent revision of lt knee replacement. Intra-operative per surgeon noted femoral component to have rotation between the end of the femur.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 391025
• MDR Report Key: 391025
• Date Received: 2002-04-30
• Date of Report: 2002-03-12
• Date of Event: 2002-02-27
• Date Facility Aware: 2002-02-27
• Report Date: 2002-03-12
• Date Reported to Mfgr: 2002-03-12
• Date Added to Maude: 2002-05-02
• 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: LT TOTAL KNEE PROSTHESIS
• Generic Name: KNEE COMPONENTS
• Product Code: KRQ
• Date Received: 2002-04-30
• Model Number: X
• Catalog Number: *
• Lot Number: *
• ID Number: LEFT
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 4 YR
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 380071
• Manufacturer: BIOMET, INC.
• Manufacturer Address: PO BOX 587 WARSAW IN 465810587 US

Device Sequence Number: 2

• Brand Name: LT TOTAL KNEE PROSTHESIS
• Generic Name: KNEE COMPONENT
• Product Code: KRQ
• Date Received: 2002-04-30
• Model Number: CP110377
• Catalog Number: *
• Lot Number: *
• ID Number: CR-COMD
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 4 YR
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 2
• Device Event Key: 380084
• Manufacturer: BIOMET INC
• Manufacturer Address: PO BOX 587 WARSAW IN 465810587 US

Device Sequence Number: 3

• Brand Name: LT TOTAL KNEE PROSTHESIS
• Generic Name: KNEE COMPONENTS
• Product Code: KRQ
• Date Received: 2002-04-30
• Model Number: B077100
• Catalog Number: *
• Lot Number: *
• ID Number: 12MM STD
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 4 YR
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 3
• Device Event Key: 380088
• Manufacturer: BIOMET, INC
• Manufacturer Address: PO BOX 587 WARSAW IN 465810587 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2002-04-30