MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP LT SZ 3; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED

Catalog Number	74021163
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery was performed due to pain and dislocation of patella bone.Femoral component and inserts were exchanged.
Additional Manufacturer Narrative
The associated complaint device was not returned.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.The medical investigation concluded that, without the requested clinical information, a thorough medical investigation cannot be rendered.Should any additional clinical information be provided this complaint will be re-evaluated.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: JRNY II CR FEM OX NP LT SZ 3
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMICONSTRAINED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9109439
• Report Number: 1020279-2019-03463
• Device Sequence Number: 19729779
• Product Code: JWH
• UDI-Device Identifier: 00885556422809
• UDI-Public: 00885556422809
• Combination Product (Y/N): N
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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: 74021163
• Device Lot Number: 18DM19803
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 12/03/2019
• 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: LINER 74023720/ 17HM13109.; LINER 74023820/ 17GM04691.; LINER 74023720/ 17HM13109; LINER 74023820/ 17GM04691
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention