MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP LT SZ 5; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	74021165
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	10/31/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient has complained of pain in the knee since the initial procedure.Revision surgery was performed.No delay, additional injuries or back up reported.
Additional Manufacturer Narrative
The associated complaint devices were returned for evaluation.The visual inspection of the oxinium femoral shows scratches on the articular surface and what appears to be bone cement and bone on the ap box surface.On the baseplate there appears to be bone and cement on the inferior surfaces with scratches and gouges on the superior surfaces.Also there is also bone, tissue and cement.There are scratches and wear marks on the articular surfaces of the inserts.A review of the complaint history revealed no prior complaints for the listed lots.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.Our clinical team noted that no clinically relevant supporting documentation was provided for inclusion in a medical investigation.The patient impact beyond the reported pain and the revision procedure cannot be concluded.Should clinically relevant documentation become available, the clinical/medical assessment may be re-evaluated.No further medical assessment can be rendered at this time.The cause of the reported pain could not be determined from the information provided.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.We consider this investigation closed.
Additional Manufacturer Narrative
Correct explant date added.

• Brand Name: JRNY II CR FEM OX NP LT SZ 5
• 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: 8030437
• Report Number: 1020279-2018-02267
• Device Sequence Number: 1382648
• Product Code: JWH
• UDI-Device Identifier: 00885556422786
• UDI-Public: 00885556422786
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2019

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 Catalogue Number: 74021165
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 10/24/2018; 10/24/2018
• Initial Report FDA Received Date: 11/01/2018
• Supplement Report FDA Received Date: 03/14/2019; 06/20/2019
• 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