MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II BICONVEX PAT 26MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	71420568
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	10/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 1st stage revision of a genesis ii tkr from 2004 was performed.It was revised due to infection.Early this year, the knee was washed out, and the polyethylene was revised in an attempt to clear the infection.Original op notes are not available, so lot numbers etc are unavailable.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, all documents and/or images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.No relevant supporting clinical information has been provided to assist with a clinical investigation, and the patient's current condition is unknown.Therefore based on insufficient information, a thorough clinical assessment cannot be performed at this time.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: GNS II BICONVEX PAT 26MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8034891
• Report Number: 1020279-2018-02335
• Device Sequence Number: 19198508
• Product Code: JWH
• UDI-Device Identifier: 03596010208262
• UDI-Public: 03596010208262
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K951987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2019

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 Catalogue Number: 71420568
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 05/03/2019
• 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; Required Intervention