GENESIS II TOTAL KNEE REPLACEMENT SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for GENESIS II TOTAL KNEE REPLACEMENT SYSTEM manufactured by Smith And Nephew, Inc..

Event Text Entries

[185929040] The smith & nephew poly and patella implant failed from previous total knee surgery resulting in pt needing a total knee revision. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5093972
• MDR Report Key: 9902731
• Date Received: 2020-03-30
• Date of Report: 2020-03-26
• Date of Event: 2020-03-06
• Date Added to Maude: 2020-03-31
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: GENESIS II TOTAL KNEE REPLACEMENT SYSTEM
• Generic Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLY
• Product Code: JWH
• Date Received: 2020-03-30
• Lot Number: 14JM19093
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SMITH AND NEPHEW, INC.
• Manufacturer Address: CORDOVA TN 38016 US 38016

Device Sequence Number: 2

• Brand Name: GENESIS II TOTAL KNEE REPLACEMENT SYSTEM
• Generic Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLY
• Product Code: JWH
• Date Received: 2020-03-30
• Lot Number: 13JM13287
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: SMITH AND NEPHEW, INC.
• Manufacturer Address: CORDOVA TN 38016 US 38016

Device Sequence Number: 3

• Brand Name: GENESIS II TOTAL KNEE REPLACEMENT SYSTEM
• Generic Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLY
• Product Code: JWH
• Date Received: 2020-03-30
• Lot Number: 15AM14592
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: SMITH AND NEPHEW, INC.
• Manufacturer Address: CORDOVA TN 38016 US 38016

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2020-03-30