* 1872-0518

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-09-16 for * 1872-0518 manufactured by Wright Medical Tech.

Event Text Entries

[160279] Aseptic loosening of both femoral and tibial components with fracture of morse taper of tibial and femoral components of left total knee replacements. 13 months post left total knee replacement. Originally doing well 4-99 began developing pain; progressively worse proceded with revision 8-30-99.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 241451
• MDR Report Key: 241451
• Date Received: 1999-09-16
• Date of Report: 1999-09-16
• Date of Event: 1999-08-30
• Date Facility Aware: 1999-08-30
• Report Date: 1999-09-12
• Date Reported to FDA: 1999-09-16
• Date Reported to Mfgr: 1999-08-30
• Date Added to Maude: 1999-09-23
• 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
• Reporter Occupation: RISK MANAGER
• 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: *
• Generic Name: FEMORAL COMPONENT
• Product Code: KRP
• Date Received: 1999-09-16
• Returned To Mfg: 1999-08-31
• Model Number: 1872-0518
• Catalog Number: *
• Lot Number: 087A069326
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: 13 MO
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 233930
• Manufacturer: WRIGHT MEDICAL TECH
• Manufacturer Address: * ARLINGTON TN 38002 US
• Baseline Brand Name: ADVANTIM SMOOTH TIBIAL STEM
• Baseline Generic Name: KNEE COMPONENT
• Baseline Catalog No: 1872-0613
• Baseline Device Family: K J 888.3560
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: Y
• Baseline Transitional: N
• 510k Exempt: N

Device Sequence Number: 2

• Brand Name: *
• Generic Name: TIBIAL COMPONENT
• Product Code: HSH
• Date Received: 1999-09-16
• Returned To Mfg: 1999-08-31
• Model Number: 1872-0613
• Catalog Number: *
• Lot Number: 048A0074101
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: 13 MO
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 2
• Device Event Key: 233931
• Manufacturer: WRIGHT MEDICAL TECH
• Manufacturer Address: * ARLINGTON TN 38002 US

Device Sequence Number: 3

• Brand Name: *
• Generic Name: PATELLA
• Product Code: HTG
• Date Received: 1999-09-16
• Returned To Mfg: 1999-08-31
• Model Number: 1840-6312
• Catalog Number: *
• Lot Number: 048A079500
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: 13 MO
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 3
• Device Event Key: 233932
• Manufacturer: WRIGHT MEDICAL TECH
• Manufacturer Address: * ARLINGTON TN 38002 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1999-09-16