MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74027262
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/08/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to severe pain along with snapping and grinding over the anterolateral aspect of the knee.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, without the requested clinical documents a thorough medical investigation cannot be rendered.Should any additional clinically supporting documents become available this complaint will be re-assessed.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.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.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, without the requested clinical documents a thorough medical investigation cannot be rendered.Should any additional clinically supporting documents become available this complaint will be re-assessed.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed batches.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: JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8420936
• Report Number: 1020279-2019-01064
• Device Sequence Number: 18892048
• Product Code: JWH
• UDI-Device Identifier: 00885556178010
• UDI-Public: 00885556178010
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/02/2019

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 Expiration Date: 11/21/2025
• Device Catalogue Number: 74027262
• Device Lot Number: 15LM18443
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 03/05/2019; 03/05/2019; 03/05/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 06/17/2019; 06/17/2019; 07/02/2019
• 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