MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR ISRT XLPE RT SZ 1-2 12MM; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74025614
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/25/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported right traumatic arthrotomy status post fall, removal of foreign body and revision of poly.
Additional Manufacturer Narrative
The associated complaint device was not returned.The medical investigation concluded that, reportedly, the patient underwent a revision surgery following a fall.The date of implantation is unknown.During the revision irrigation and debridement was performed.It was also communicated that removal of foreign body was took place and the polyethylene component was revised.Details regarding the patient¿s weight-bearing status, medical history, bone quality, x-ray images, and other additional clinical relevant information have not been provided.Based on the information provided, the revision was due to a fall sustained by the patient and not a mal-performance of the implant.The patient¿s status has been reported as resolved.No further clinical/medical assessment is warranted at this time.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, the complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: JRNY II CR ISRT XLPE RT SZ 1-2 12MM
• 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: 8940106
• Report Number: 1020279-2019-03206
• Device Sequence Number: 2099149
• Product Code: JWH
• UDI-Device Identifier: 00885556422717
• UDI-Public: 00885556422717
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2019

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: 09/10/2022
• Device Catalogue Number: 74025614
• Device Lot Number: 12JM06252
• Initial Date Received by Manufacturer: 08/01/2019
• Supplement Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 11/22/2019
• 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