MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEMORAL OXIN LT SZ 4; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLY

Catalog Number	74022124
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/17/2014
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that revision surgery would be required to correct a patellofemoral maltracking.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, based on the information provided, the root cause of the patient¿s symptoms remains unknown, however, the reported suspected ¿scar reaction¿, noted increased lateral patellar displacement, and moderate left coxarthrosis cannot be ruled out as possible contributing factors to the patients pain and other symptoms.The patient impact beyond the reported left knee pain, crepitus, clicking occasional locking cannot be concluded, as no interventions other than pt have been initiated to date per the patients request for a conservative approach as per documented communications.No further medical assessment is warranted 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.

• Brand Name: JRNY BCS II FEMORAL OXIN LT SZ 4
• Common Device Name: PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAINED,CEMENTED,POLYMER/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7181618
• Report Number: 1020279-2018-00038
• Device Sequence Number: 1177913
• Product Code: JWH
• UDI-Device Identifier: 00885556170366
• UDI-Public: 00885556170366
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K111711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2018

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 Catalogue Number: 74022124
• Device Lot Number: 13FM14530
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 01/11/2018
• Supplement Report FDA Received Date: 04/22/2018
• 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
• Patient Age: 71 YR
• Patient Weight: 70