MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY FEM OX NP BCS RT SZ 8; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	74021118
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/01/2009
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after surgery, right tkr, the patient suffered from discomfort and repetitive bleeding episodes.

• Brand Name: JOURNEY FEM OX NP BCS RT SZ 8
• 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: 9820362
• Report Number: 1020279-2020-00829
• Device Sequence Number: 16915751
• Product Code: JWH
• UDI-Device Identifier: 03596010554093
• UDI-Public: 03596010554093
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2020

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: 03/10/2017
• Device Model Number: 74021118
• Device Catalogue Number: 74021118
• Device Lot Number: 07CM08026
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 11/26/2020
• 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