MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GENESIS II C/R ART INS SZ 3-4 9MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POL/METAL/POLY

Catalog Number 71420490

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem Injury (2348)

Event Date 11/04/2019

Event Type  Injury  

Event Description

It was reported that the patient had smith+nephew components since (b)(6) 2014.Revision surgery was performed on (b)(6) 2019 due to arthrosis on the right with inlay wear.

• Brand Name: GENESIS II C/R ART INS SZ 3-4 9MM
• Type of Device: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POL/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: holly topping ; west william cannon drive; austin, TX
• MDR Report Key: 9873871
• MDR Text Key: 184728656
• Report Number: 1020279-2020-00993
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K951987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 71420490
• Device Lot Number: 14FT42853
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/03/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention