WRIGHT MEDICAL TECHNOLOGY 1885-0300 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-08-20 for WRIGHT MEDICAL TECHNOLOGY 1885-0300 * manufactured by Wright Medical Technology, Inc..

Event Text Entries

[18953178] Loose tibial component resulting in loose femoral component. Initial left total knee 2/24/95.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 183854
• MDR Report Key: 183854
• Date Received: 1998-08-20
• Date of Report: 1998-01-08
• Date of Event: 1998-01-08
• Date Added to Maude: 1998-08-26
• 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: WRIGHT MEDICAL TECHNOLOGY
• Generic Name: FEMORAL
• Product Code: JWH
• Date Received: 1998-08-20
• Model Number: 1885-0300
• Catalog Number: *
• Lot Number: 15903314
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: 3 YR
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 178748
• Manufacturer: WRIGHT MEDICAL TECHNOLOGY, INC.
• Manufacturer Address: * * *
• Baseline Brand Name: ADVANTIM NONPOROUS CF TIBIAL BASE
• Baseline Generic Name: KNEE COMPONENT
• Baseline Model No: *
• Baseline Catalog No: 1885-0300
• Baseline ID: *
• Baseline Device Family: K J 888.3560
• Baseline Shelf Life Contained: N
• Baseline Shelf Life [Months]: 96
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: Y
• Baseline Transitional: N
• 510k Exempt: N

Device Sequence Number: 2

• Brand Name: WRIGHT MEDICAL TECHNOLOGY
• Generic Name: TIBIAL BASE
• Product Code: JWH
• Date Received: 1998-08-20
• Model Number: 1895-0014
• Catalog Number: *
• Lot Number: A007479
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: 3 YR
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 2
• Device Event Key: 178749
• Manufacturer: WRIGHT MEDICAL TECHNOLOGY, INC
• Manufacturer Address: * * *
• Baseline Brand Name: ADVANTIM NONPOROUS POSTERIOR STABILIZED FEMORAL
• Baseline Generic Name: KNEE COMPONENT
• Baseline Model No: *
• Baseline Catalog No: 1895-0014
• Baseline ID: *
• Baseline Device Family: K J 888.3560
• Baseline Shelf Life Contained: N
• Baseline Shelf Life [Months]: 96
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: Y
• Baseline Transitional: N
• 510k Exempt: N

Device Sequence Number: 3

• Brand Name: WRIGHT MEDICAL TECHNOLOGY
• Generic Name: TIBIAL INSERT
• Product Code: KRP
• Date Received: 1998-08-20
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: 3 YR
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 3
• Device Event Key: 178750
• Manufacturer: WRIGHT MEDICAL TECHNOLOGY, INC
• Manufacturer Address: * * *
• Baseline Brand Name: DURAMER ADVANTIM POST STAB LSI TIBIAL INSERT
• Baseline Generic Name: KNEE COMPONENT
• Baseline Catalog No: 1890-3314
• 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. Hospitalization; 2. Required No Informationntervention	1998-08-20