MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY FEM OX NP BCS LT SZ 6; PROST, KNEE, PATFEMTIB, SEMI-CNSTRND, CMNTD, POLY/METAL/POLY

Catalog Number	74021126
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Thrombosis/Thrombus (4440)
Date of Event	04/16/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Us legal.Bilateral patient.It was reported that, after a tka construct had been implanted on the plaintiff's left knee on (b)(6) 2011, the plaintiff experienced a lower extremity peritoneal vein thrombosis (dvt).This adverse event was treated with coumadin for 3 months.After this, no recurrent dvts or pulmonary embolisms were reported to occur.

• Brand Name: JOURNEY FEM OX NP BCS LT SZ 6
• Common Device Name: PROST, KNEE, PATFEMTIB, SEMI-CNSTRND, CMNTD, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12541851
• Report Number: 1020279-2021-07256
• Device Sequence Number: 11139992
• Product Code: JWH
• UDI-Device Identifier: 03596010554178
• UDI-Public: 3596010554178
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2021

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: 08/09/2020
• Device Catalogue Number: 74021126
• Device Lot Number: 10GM17122A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 11/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 74022225 / JOURNEY TIBIA BASE NP LT SZ 5; 74023262 / JOURN ART INSERT BCS STD 5-6 LT10; 74024832 / JRNY BCS PAT RESRF RD 32 MM STD; 74022225 / JOURNEY TIBIA BASE NP LT SZ 5; 74023262 / JOURN ART INSERT BCS STD 5-6 LT10; 74024832 / JRNY BCS PAT RESRF RD 32 MM STD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR