MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE LT SZ 5-6 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	14CM17308
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	04/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Contralateral revision has been submitted under mdr 1020279-2017-00360.It was reported to us that explants have been kept by the facility and cannot be returned.
Event or Problem Description
It was reported that a revision surgery was performed with exchange of a tibial insert to a thicker dished one as the patient was unstable in the knee.
Additional Manufacturer Narrative
Corrections since the initialy reported batch number was discovered to be invalid.
Additional Manufacturer Narrative
The device related to this complaint was not returned.Please check the attached file to see our investigation results.(b)(4).

• Brand Name: JRNY II CR ISRT XLPE LT SZ 5-6 10MM
• 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: 6583794
• Report Number: 1020279-2017-00361
• Device Sequence Number: 16166146
• Product Code: JWH
• UDI-Device Identifier: 00885556422458
• UDI-Public: 00885556422458
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2017

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: 03/22/2024
• Device Model Number: 14CM17308
• Device Catalogue Number: 14CM17308
• Device Lot Number: 14CM17308
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/25/2017
• Supplement Date Received by Manufacturer: 04/25/2017; 04/25/2017
• Initial Report FDA Received Date: 05/23/2017
• Supplement Report FDA Received Date: 08/11/2017; 10/03/2017
• 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; Required Intervention