MAUDE Adverse Event Report: SMITH AND NEPHEW, INC. GENESIS II TOTAL KNEE REPLACEMENT SYSTEM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLY

Lot Number 13JM13287

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Code Available (3191)

Event Date 03/06/2020

Event Type  malfunction  

Event Description

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).

• Brand Name: GENESIS II TOTAL KNEE REPLACEMENT SYSTEM
• Type of Device: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLY
• Manufacturer (Section D): SMITH AND NEPHEW, INC. ; cordova TN 38016
• MDR Report Key: 9902731
• MDR Text Key: 185929040
• Report Number: MW5093972
• Device Sequence Number: 2
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/26/2020
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 13JM13287
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Weight: 51