MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CEM TIB SIZE 8 RIGHT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number	71420191
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/24/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a right knee revision was performed due to subsidence and loosening of the right tibial baseplate.
Additional Manufacturer Narrative
We found out that part number71421523/ lot number unknown was a duplicate device.The only concomitant medical devices are part 71421523/ lot 11dt06058 and part 71420174/lot 10et42396.Please refer to previous supplemental report for investigation results.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see attached file for the results of our investigation.(b)(4).

• Brand Name: GNS II CEM TIB SIZE 8 RIGHT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6651133
• Report Number: 1020279-2017-00440
• Device Sequence Number: 1285402
• Product Code: JWH
• UDI-Device Identifier: 03596010206381
• UDI-Public: 03596010206381
• 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: 2011
• 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): 09/28/2017

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: 03/28/2020
• Device Catalogue Number: 71420191
• Device Lot Number: 10CT40709
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/24/2017
• Supplement Date Received by Manufacturer: 05/24/2017; 05/24/2017
• Initial Report FDA Received Date: 06/19/2017
• Supplement Report FDA Received Date: 09/28/2017; 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71420174/10ET42396; 71421523/11DT06058; 71421523/UNKNOWN
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention