DURAMER ADVANTIM POST. STAB. LSI TIBIAL INSERT 1890-3212

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 1998-12-09 for DURAMER ADVANTIM POST. STAB. LSI TIBIAL INSERT 1890-3212 manufactured by Wright Medical Technology, Inc..

Event Text Entries

[119519] Allegedly revision performed due to loosening of component.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1043534-1998-00115
• MDR Report Key: 201461
• Report Source: 05,07
• Date Received: 1998-12-09
• Date of Report: 1998-11-10
• Date of Event: 1998-11-10
• Date Mfgr Received: 1998-11-10
• Device Manufacturer Date: 1994-11-01
• Date Added to Maude: 1998-12-15
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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: 3
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DURAMER ADVANTIM POST. STAB. LSI TIBIAL INSERT
• Generic Name: KNEE COMPONENT
• Product Code: KRP
• Date Received: 1998-12-09
• Returned To Mfg: 1998-11-19
• Model Number: NA
• Catalog Number: 1890-3212
• Lot Number: 114A009440
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 195681
• Manufacturer: WRIGHT MEDICAL TECHNOLOGY, INC.
• Manufacturer Address: 5677 AIRLINE RD. ARLINGTON TN 38002 US
• Baseline Brand Name: DURAMER ADVANTIM POST STAB LSI TIBIAL INSERT
• Baseline Generic Name: KNEE COMPONENT
• Baseline Catalog No: 1890-3212
• 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	1998-12-09