ORTHOLOC ADVANTIM LSI TIBIAL INSERT 1870-3110

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-08-11 for ORTHOLOC ADVANTIM LSI TIBIAL INSERT 1870-3110 manufactured by Wright Medical Technology, Inc..

Event Text Entries

[21397530] Allegedly had revision due to worn poly. All other components looked great.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1043534-1998-00057
• MDR Report Key: 182218
• Report Source: 05
• Date Received: 1998-08-11
• Date of Report: 1998-07-14
• Date of Event: 1998-06-23
• Date Mfgr Received: 1998-07-14
• Device Manufacturer Date: 1991-09-01
• Date Added to Maude: 1998-08-17
• 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: ORTHOLOC ADVANTIM LSI TIBIAL INSERT
• Generic Name: KNEE COMPONENT
• Product Code: KRP
• Date Received: 1998-08-11
• Returned To Mfg: 1998-07-14
• Model Number: NA
• Catalog Number: 1870-3110
• Lot Number: 091M651100
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: N
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 177167
• Manufacturer: WRIGHT MEDICAL TECHNOLOGY, INC.
• Manufacturer Address: 5677 AIRLINE ROAD ARLINGTON TN 38002 US
• Baseline Brand Name: ORTHOLOC ADVANTIM LSI TIBIAL INSERT
• Baseline Generic Name: KNEE COMPONENT
• Baseline Model No: NA
• Baseline Catalog No: 1870-3110
• 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	1998-08-11