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	Fracture (1260)
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 that patient sustained a traumatic fall at home which resulted in traumatic arthrotomy of the knee.Patient was taken to surgery for irrigation, debridement, removal of foreign body, hematoma and revision of polyethylene component.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation was conducted and although clinically relevant supporting documentation was not provided and a thorough medical investigation could not be performed, it was reported that the revision performed approximately 1.5 weeks post implantation was due to a fall which resulted in a traumatic arthrotomy.The event was reportedly resolved and no further patient impact is anticipated.No further medical assessment can be rendered at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• 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: 8683944
• Report Number: 1020279-2019-02256
• Device Sequence Number: 2292840
• 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
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2019

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: 74025614
• Device Lot Number: 12JM06252
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 06/10/2019
• Supplement Report FDA Received Date: 11/29/2019
• 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