WRIGHT MEDICAL TECH * 1890-3216

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-09-02 for WRIGHT MEDICAL TECH * 1890-3216 manufactured by Wright Medical.

Event Text Entries

[143314] Painful left total knee arthroplasty secondary to loose femoral and tibial components. Disruption extensor mechanism.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 208733
• MDR Report Key: 208733
• Date Received: 1997-09-02
• Date of Report: 1997-05-08
• Date of Event: 1997-04-01
• Date Facility Aware: 1997-04-01
• Report Date: 1997-05-13
• Date Reported to Mfgr: 1997-05-13
• Date Added to Maude: 1999-02-08
• 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: WRIGHT MEDICAL TECH
• Generic Name: LEFT TOTAL KNEE
• Product Code: KRP
• Date Received: 1997-09-02
• Model Number: *
• Catalog Number: 1890-3216
• Lot Number: 104A004908
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 90778
• Manufacturer: WRIGHT MEDICAL
• 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: 1890-3216
• 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	1997-09-02