MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII CM TIB SIZE 2 {} RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CEMNTD,POLYMR/METL/POLYMER

Catalog Number 71420180

Device Problem Misconnection (1399)

Patient Problem Injury (2348)

Event Date 09/06/2017

Event Type  Injury  

Event Description

It was reported that a right tibial revision surgery was performed due to insert not engaging with the tibial baseplate.

Manufacturer Narrative

Please notice there was an error in the manufacturer number, the correct number corresponds to (b)(4) manufacturer site (b)(4).

• Brand Name: GII CM TIB SIZE 2 {} RIGHT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CEMNTD,POLYMR/METL/POLYMER
• 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: markus poettker ; 1450 brooks road; memphis, TN 38116
• MDR Report Key: 6874409
• MDR Text Key: 86557542
• Report Number: 8010764-2017-00001
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 00885556034804
• UDI-Public: 00885556034804
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71420180
• Device Lot Number: 16CM14459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2017
• Initial Date FDA Received: 09/18/2017
• Supplement Dates Manufacturer Received: 09/06/2017; 09/06/2017
• Supplement Dates FDA Received: 09/28/2017; 12/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2016
• 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; Other; Required Intervention