MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II CR FEM OX NP RT SZ 4; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number	74021154
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Swelling (2091)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient has been having swelling and a warm sensation in the right knee.The patient has had a cortisone shot and is currently taking tramadol.The patient is allergic to nickel.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.
Additional Manufacturer Narrative
The associated complaint devices were not returned.Based on the available medical reports, the root cause for this patient's symptoms cannot be concluded.The reported varus alignment of the tibial component was reported as the cause of the patient's reported pain but it's not known if the tibial alignment migrated from implantation due to the reported loosening.No revision has taken place at this time.If a revision is performed and those records become available this complaint can be re-assessed.A review of complaint history on the listed parts revealed no prior complaints for their corresponding batches with the same failure mode.A review of the manufacturing records did not reveal any manufacturing abnormalities that could have caused or contributed to the reported incident.Without the actual products involved, our investigation cannot proceed.If the devices or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: JRNY II CR FEM OX NP RT SZ 4
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7122603
• Report Number: 1020279-2017-01267
• Device Sequence Number: 1210631
• Product Code: JWH
• UDI-Device Identifier: 00885556422854
• UDI-Public: 00885556422854
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/03/2025
• Device Catalogue Number: 74021154
• Device Lot Number: 15HM03839
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2017
• Supplement Date Received by Manufacturer: 11/17/2017; 11/17/2017
• Initial Report FDA Received Date: 12/15/2017
• Supplement Report FDA Received Date: 02/17/2018; 07/12/2018
• 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: 74022213/15GM15046; 74024835/15GM22457; 74025634/14EM11995