MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY FEM OX NP BCS LT SZ 8; PRSTHSS,KNEE,PATELLOFEMOROTIBIAL,SMCONSTRAIND,CMNTD,POLYMR/METL/POLYMR

Catalog Number	74021128
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As part of its post-market surveillance (pms) and post-marketing clinical follow-up processes, smith & nephew has conducted an analysis of the national joint registry of (b)(4) orthopaedic association national joint replacement registry (aoanjrr) data on the first generation journey¿ bcs knee system.The data indicate that the system has a revision rate over 1.5 times the primary total knee arthroplasty device class average revision rates in the njrewni and aoanjrr.Therefore, a voluntary field safety corrective action (fsca) with reference (b)(4) was submitted on 13 jun 2018 for the first generation of journey bcs manufactured by smith & nephew inc.(b)(4).
Event or Problem Description
It was reported a revision surgery was performed and the implants were removed.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, no clinical relevant documents were provided to conduct a thorough medical assessment.No medical assessment is warranted at this time.This complaint will be re-evaluated if more information becomes available.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch/failure mode.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: JOURNEY FEM OX NP BCS LT SZ 8
• Common Device Name: PRSTHSS,KNEE,PATELLOFEMOROTIBIAL,SMCONSTRAIND,CMNTD,POLYMR/METL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7639256
• Report Number: 1020279-2018-01210
• Device Sequence Number: 19279735
• Product Code: JWH
• UDI-Device Identifier: 03596010554185
• UDI-Public: 03596010554185
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K042515
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2018

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 Expiration Date: 02/13/2018
• Device Catalogue Number: 74021128
• Device Lot Number: 08BM12682
• Initial Date Received by Manufacturer: 06/12/2018
• Supplement Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 09/14/2018
• 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