TOTAL KNEE 1870-3212 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-06-29 for TOTAL KNEE 1870-3212 * manufactured by Wright Medical Technology, Inc..

Event Text Entries

[16290529] Surgical procedure. Right total knee with polyethylene wear. Painful right knee.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 285227
• MDR Report Key: 285227
• Date Received: 2000-06-29
• Date of Report: 2000-04-27
• Date of Event: 2000-04-27
• Date Facility Aware: 2000-04-27
• Report Date: 2000-04-27
• Date Reported to Mfgr: 2000-06-26
• Date Added to Maude: 2000-07-12
• 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 Details

• Brand Name: TOTAL KNEE
• Generic Name: INSERT
• Product Code: KRP
• Date Received: 2000-06-29
• Model Number: 1870-3212
• Catalog Number: *
• Lot Number: 112ME09590
• ID Number: *
• Device Availability: N
• Device Age: 7 YR
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 273315
• Manufacturer: WRIGHT MEDICAL TECHNOLOGY, INC.
• Manufacturer Address: 5677 AIRLINE RD. ARLINGTON TN * US
• Baseline Brand Name: ORTHOLOC ADVANTIM LSI TIBIAL INSERT
• Baseline Generic Name: KNEE COMPONENT
• Baseline Model No: NA
• Baseline Catalog No: 1870-3212
• Baseline ID: NA
• 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

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2000-06-29