MAUDE Adverse Event Report: SMITH AND NEPHEW INC JOURNEY TIBIA BASE NP RT SZ 7; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74022217
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/25/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a serious injury during clinical study in which there was infection in right knee.Right peri-prosthetic infection with i&d x 2 and poly exchange.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that there is just one device implicated in the event, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: JOURNEY TIBIA BASE NP RT SZ 7
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH AND NEPHEW INC; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7858751
• Report Number: 1020279-2018-01755
• Device Sequence Number: 2547775
• Product Code: JWH
• UDI-Device Identifier: 03596010554390
• UDI-Public: 03596010554390
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2018

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: 74022217
• Device Lot Number: 18DM09680
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 09/09/2018
• Supplement Report FDA Received Date: 10/02/2018
• 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