WRIGHT MEDICAL TECHNOLOGY TIBIAL C.F., INSERT 18850300, 189033

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-08-06 for WRIGHT MEDICAL TECHNOLOGY TIBIAL C.F., INSERT 18850300, 189033 manufactured by Wright Medical Technology.

Event Text Entries

[17430430] Loose tibial component.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 111804
• MDR Report Key: 111804
• Date Received: 1997-08-06
• Date of Report: 1997-06-19
• Date of Event: 1997-06-19
• Date Facility Aware: 1997-06-19
• Report Date: 1997-06-19
• Date Reported to Mfgr: 1997-07-03
• Date Added to Maude: 1997-08-12
• 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 Sequence Number: 1

• Brand Name: WRIGHT MEDICAL TECHNOLOGY
• Generic Name: TIBIAL COMPONENT FRIENDLY-CEMENT
• Product Code: KRP
• Date Received: 1997-08-06
• Model Number: TIBIAL C.F., INSERT
• Catalog Number: 18850300, 189033
• Lot Number: M925390, CO-CR
• ID Number: A007478 INSERT
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: *
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 109775
• Manufacturer: WRIGHT MEDICAL TECHNOLOGY
• 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: 1890-3312
• 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: WRIGHT MEDICAL TECHNOLOGY
• Generic Name: TIBIAL COMPONENT-CEMENT FRIENDLY
• Product Code: KRP
• Date Received: 1997-08-06
• Model Number: INSERT
• Catalog Number: 189033
• Lot Number: CO-CR-TIBIAL
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: *
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 2
• Device Event Key: 109775
• Manufacturer: WRIGHT MEDICAL TECH
• 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: 1890-3312
• 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	1997-08-06