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

Catalog Number	71420180
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/06/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a right tibial revision surgery was performed due to insert not engaging with the tibial baseplate.
Additional 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
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL,SEMICONSTRAIND,CEMNTD,POLYMR/METL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6874409
• Report Number: 8010764-2017-00001
• Device Sequence Number: 16482382
• Product Code: JWH
• UDI-Device Identifier: 00885556034804
• UDI-Public: 00885556034804
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 03/19/2026
• Device Catalogue Number: 71420180
• Device Lot Number: 16CM14459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Initial Date Received by Manufacturer: 09/06/2017
• Supplement Date Received by Manufacturer: 09/06/2017; 09/06/2017
• Initial Report FDA Received Date: 09/18/2017
• Supplement Report FDA Received Date: 09/28/2017; 12/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention