MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GENESIS II CEMENTED TIBIAL SIZE 5 LEFT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 71420168

Device Problems Failure To Adhere Or Bond (1031); Metal Shedding Debris (1804)

Patient Problem No Code Available (3191)

Event Date 08/18/2016

Event Type  Injury  

Manufacturer Narrative

Event Description

It was reported that a revision surgery was performed with exchange of tibial tray and articular component due to loosening.Surgeon booked the surgery for a poly exchange.Intraoperatively he discovered extensive metallosis in the surrounding tissues and that the tibial tray was loose.

• Brand Name: GENESIS II CEMENTED TIBIAL SIZE 5 LEFT
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: claudia odoy ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 5910274
• MDR Text Key: 53337543
• Report Number: 1020279-2016-00671
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K951987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71420168
• Device Catalogue Number: 71420168
• Device Lot Number: 13AT27576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR