MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE LT SZ 1-2 11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74025623
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Contralateral revision has been reported under mdr 1020279-2017-00362.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
[(b)(4)].

• Brand Name: JRNY II CR ISRT XLPE LT SZ 1-2 11MM
• 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: 6583846
• Report Number: 1020279-2017-00363
• Device Sequence Number: 613694
• Product Code: JWH
• UDI-Device Identifier: 00885556422656
• UDI-Public: 00885556422656
• 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
• Report Date (Section B): 10/05/2017

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: 10/08/2022
• Device Catalogue Number: 74025623
• Device Lot Number: 12KM06750
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2017
• Supplement Date Received by Manufacturer: 05/23/2017
• Initial Report FDA Received Date: 05/23/2017
• Supplement Report FDA Received Date: 10/05/2017
• 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