MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY FEM OX NP BCS RT SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74021114
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/06/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to knee instability.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, based on the documentation provided, the root cause of the reported unstable right knee cannot be concluded; however, currently unable to rule out the patient¿s reported peripheral neuropathy/potentially weakened supporting soft tissues and/or micro-motion of the tibial component as possible contributing factors to the reported event.The patient impact beyond the reported unstable knee, revision to competitor components, and an expected brief post-operative rehabilitation phase cannot be concluded.No further medical assessment can be rendered at this time.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 parts revealed no prior complaints for the listed batches.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.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, based on the documentation provided, the root cause of the reported unstable right knee cannot be concluded; however, currently unable to rule out the patient¿s reported peripheral neuropathy, potentially weakened supporting soft tissues, questionable cement application/adherence and/or micro-motion of the tibial component as possible contributing factors to the reported event.The patient impact beyond the reported unstable knee, revision to competitor components, and an expected brief post-operative rehabilitation phase could not be concluded.No further medical assessment can be rendered at this time.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 parts revealed no prior complaints for the listed batches.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: JOURNEY FEM OX NP BCS RT SZ 4
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8020602
• Report Number: 1020279-2018-02307
• Device Sequence Number: 1640788
• Product Code: JWH
• UDI-Device Identifier: 03596010554062
• UDI-Public: 03596010554062
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2019

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 Expiration Date: 01/11/2019
• Device Catalogue Number: 74021114
• Device Lot Number: 09AM08526
• Initial Date Received by Manufacturer: 10/04/2018
• Supplement Date Received by Manufacturer: 10/04/2018; 10/04/2018
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 05/04/2019; 10/15/2019
• 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
• Patient Age: 59 YR